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Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067

NCT04787042
Recruiting
Conditions Cancer, Solid Tumor, Melanoma, Renal Cel...
Phase PHASE1, PHASE2
Enrollment 316
Locations 6 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Non Randomized Intervention model: Sequential Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Biological: ST-067 — ST-067 is an engineered variant of human interleukin-18.
  • Biological: Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA] — Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B-cells.
  • Biological: pembrolizumab — Pembrolizumab is a potent humanized immunoglobulin G4 monoclonal antibody.

Primary Outcomes

  • Determine the maximum tolerated dose of ST-067 in phase 1a monotherapy (Day 29)
  • Evaluate the overall safety and tolerability of ST-067 in combination with pembrolizumab (Day 29)
  • Number of Participants With Treatment-Related Adverse Events (Day 29)
  • Initial assessment of efficacy in phase 2 (At 8 weeks)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2021-08-06
Completion: 2025-12-31
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 316 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Simcha IL-18, Inc.
Collaborators: Merck Sharp & Dohme LLC
Principal Investigators:
  • Jeremy Barton, MD (STUDY_DIRECTOR) - Simcha IL-18, Inc.
Contact Information
Study Contact:
Beatrice McQueen, Ph.D.
805-300-3912
beatrice@simchatherapeutics.com
Justin Moser, MD
HonorHealth Research Institute
Gerald Falchook, MD, MS
Sarah Cannon Research Institute at HealthONE
Interventions
  • Biological: ST-067 — ST-067 is an engineered variant of human interleukin-18.
  • Biological: Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA] — Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B-cells.
  • Biological: pembrolizumab — Pembrolizumab is a potent humanized immunoglobulin G4 monoclonal antibody.
Study Locations (6 sites)
HonorHealth Research Institute, Scottsdale, Arizona 85258 United States
Sarah Cannon Research Institute at HealthONE, Denver, Colorado 80218 United States
Yale Cancer Center, New Haven, Connecticut 06519 United States
Moffitt Cancer Center, Tampa, Florida 33612 United States
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Roswell Park Cancer Institute, Buffalo, New York 14263 United States
Eligibility Criteria
Inclusion Criteria: 1. Male and female patients aged ≥18 years 2. Must provide written informed consent and any authorizations required by local law 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor For Phase 1a, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC,TNBC, SCCHN, microsatellite instability high, high tumor mutation burden (Hi TMB) or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, hepatocellular carcinoma and platinum resistant ovarian cancer. 1. For patients who have developed disease progression through standard therapy, or 2. For patients whom standard of care therapy that prolongs survival is unavailable or unsuitable (according to the investigator and after consultation with the Medical Monitor) For Phase 1 combination therapy dose escalation, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC (with no EGFR, TRK receptor, or ALK positive mutations/fusions), TNBC, SCCHN, MSI-Hi tumors, Hi TMB or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, and HCC * TNBC is diagnosed in a tumor which does not express estrogen receptor or progesterone receptor, is not human epidermal growth factor receptor 2 (HER2) 3+ on IHC or is negative by fluorescence in situ hybridization (FISH). * MSI high tumor should have mutations in 30% or more microsatellites by PCR or be negative for MSH1/2/6 or PMS-2 by IHC. * Hi-TMB high tumor has 10 mut/Mb or greater calculated from whole genome sequencing or whole exome sequencing For Phase 2, the following solid tumors are allowed: Melanoma, RCC, TNBC, NSCLC, SCCHN, and MSI-Hi tumors 5. Has at least 1 measurable lesion per RECIST 1.1 criteria which has not been biopsied or received prior irradiation 6. Has an accessible tumor for biopsy pre- and on-treatment (mandatory). Exclusion Criteria: 1. History of another malignancy 2. Known symptomatic brain metastases requiring \>10 mg/day of prednisolone or equivalent 3. Significant cardiovascular disease (MI, thrombotic events,) within 6 months prior to study treatmentSignificant ECG abnormalities (Phase 1a and 2 monotherapy only) including unstable cardiac arrhythmia requiring medication, second-degree atrioventricular block type II, third degree AV 4. Any degree of respiratory compromise (from either malignant or non-malignant disease) 5. Evidence of an ongoing systemic bacterial, fungal, or viral infection 6. Has received a live vaccine within 30 days 7. Major surgery within 4 weeks 8. Prior solid organ or bone marrow progenitor cell transplantation 9. Prior high dose chemotherapy requiring stem cell rescue 10. History of active autoimmune disorders 11. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids. 12. Treatment with an approved, systemic anticancer therapy or an investigational agent within 4 weeks of Day 1 13. A positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral test within 28 days prior to dosing, unless there is Investigator-confirmed clinical recovery on or before C1D1 14. Subjects with adrenal insufficiency 15. Subjects with any chemistry or hematology laboratory values that are ≥Grade 2 Additional exclusion criteria for Phase 1 combination therapy only: 16. Presence of known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 17. Prior radiotherapy within 2 weeks of start of study treatment or history of radiation pneumonitis. 18. Presence of an active documented autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or insulin) is not considered a form of systemic treatment and is allowed. Subjects may use topical and/or inhaled corticosteroids. However, subjects with adrenal insufficiency on replacement doses of steroids are not allowed. 19. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE 20. Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. Subjects who have been retreated after such a reaction may be allowed after discussion with the Simcha Medical Monitor 21. History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease 22. Subjects that have received radiation therapy to the lung that is \>30Gy within 6 months of the first dose of study treatment

Artificial Intelligence (AI)-Based Personalized Exercise Coaching for Patients With Breast Cancer

NCT07844941
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 60
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This prospective, single-center, randomized controlled trial aims to evaluate the effectiveness and safety of an artificial intelligence (AI)-based personalized exercise coaching system in female breast cancer survivors who have completed major cancer treatment and are clinically stable. A total of 100 eligible participants will be randomly assigned in a 1:1 ratio to either an AI-based exercise coaching group or a conventional exercise guidance group. Participants in the intervention group will receive personalized exercise recommendations generated by the AI exercise coaching system, with exercise data collected and used for dynamic adjustment of exercise guidance. Participants in the control group will receive conventional exercise recommendations provided by healthcare professionals. The intervention will last for 6 months. Exercise adherence will be evaluated as the primary outcome. Secondary outcomes will include quality of life, psychological status, physical function, exercise-related adverse events, and laboratory and metabolic parameters.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Supportive Care Masking/blinding: None

Interventions / Regimen

  • Device: AI-Based Personalized Exercise Coaching — Participants will receive individualized exercise recommendations generated by an AI-based exercise coaching system. The system provides personalized exercise guidance and uses exercise data collected to monitor exercise performance and dynamically adjust recommendations. The intervention will be delivered for 6 months.
  • Behavioral: Conventional Exercise Guidance — General exercise recommendations will be provided by healthcare professionals according to routine clinical practice.

Primary Outcomes

  • Exercise Adherence (6 months)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-07-22
Completion: 2027-03-22
Eligibility
Age: 18 Years – 70 Years
Sex: FEMALE
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai Jiao Tong University School of Medicine
Contact Information
Study Contact:
Siji Zhu, MD
021-64370045
zsj_mu@yeah.net
Xiaosong Chen, Professor
021-64370045
chenxiaosong0156@hotmail.com
Interventions
  • Device: AI-Based Personalized Exercise Coaching — Participants will receive individualized exercise recommendations generated by an AI-based exercise coaching system. The system provides personalized exercise guidance and uses exercise data collected to monitor exercise performance and dynamically adjust recommendations. The intervention will be delivered for 6 months.
  • Behavioral: Conventional Exercise Guidance — General exercise recommendations will be provided by healthcare professionals according to routine clinical practice.
Study Locations (1 sites)
Ruijin Hospital, Shanghai, Shanghai Municipality 200025 China
Eligibility Criteria
Inclusion Criteria: 1. Provision of written and dated informed consent. 2. Female participants aged 18 to 70 years. 3. Pathologically confirmed breast malignancy. 4. Completion of major cancer treatment, including surgery, chemotherapy, and/or radiotherapy, with clinically stable disease. 5. No severe cardiopulmonary dysfunction or contraindications to exercise. Exclusion Criteria: 1. Have not undergone breast cancer surgery. 2. Mental or psychological condition, as judged by the investigator, that would prevent adherence to the intervention or completion of follow-up.

Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer

NCT05806060
Recruiting
Conditions Triple-Negative Breast Cancer
Phase PHASE3
Enrollment 134
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The study is being conducted to evaluate VEGFR BP102 with nab-paclitaxe or treatment of physician's choice (TPC) versus nab-paclitaxe or TPC in patients for basal-like immune suppressed (BLIS) subtype of triple-negative breast cancer (TNBC) in the first-line teatment of unresectable locally advanced or metastatic TNBC.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: VEGFR and TPC — VEGFR and TPC If patients were de novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks. If patients' DFI were less than 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt, every 4 weeks, + TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).
  • Drug: TPC — If patients were de novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to control arm: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks. If patients' DFI were less than 12 months and were randomized to control arm: TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).

Primary Outcomes

  • PFS (Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years))
Interested in this trial?
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2023-04-25
Completion: 2026-11-01
Eligibility
Age: 18 Years – 70 Years
Sex: FEMALE
Volunteers: false
Enrollment: 134 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fudan University
Contact Information
Study Contact:
Zhimin Shao
86-021-64175590
zhimingshao@yahoo.com
Zhi-Ming Shao, MD
86-21-641755901105
zhimingshao@yahoo.com
Breast cancer institute of Fudan University Cancer Hospital
Lei Fan, MD
86-21-641755901105
cmchen@medmail.com.cn
Breast cancer institute of Fudan University Cancer Hospital
Interventions
  • Drug: VEGFR and TPC — VEGFR and TPC If patients were de novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks. If patients' DFI were less than 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt, every 4 weeks, + TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).
  • Drug: TPC — If patients were de novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to control arm: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks. If patients' DFI were less than 12 months and were randomized to control arm: TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).
Study Locations (1 sites)
Breast cancer institute of Fudan University Cancer Hospital, Shanghai, Shanghai Municipality 200032 China
Eligibility Criteria
Inclusion Criteria: * ECOG Performance Status of 0-1 * Expected lifetime of not less than three months * Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) with BLIS subtype * Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection * Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer * At least one measurable or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), which didn't receive radiation therapy * The functions of major organs are basically normal * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm * Have the cognitive ability to understand the protocol and be willing to participate and to be followed up Exclusion Criteria: * Symptomatic, untreated, or actively progressing CNS metastases * Significant cardiovascular disease * Adverse reactions of Grade ≥1 that are still continuing due to previous treatments. Exceptions are those of hair loss or which researchers take it as exception * Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access) * Pregnancy or breastfeeding, or intention of becoming pregnant during the study * Other malignancies within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma * Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect the use and absorption of drugs * Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites) * Participated in clinical trials of other antitumor drugs within 4 weeks before first taking the investigational drug * Long-term unhealing wound or incomplete healing of fracture * Patients with known active HBV or HCV infection or hepatitis B DNA≥500, or chronic phase with abnormal liver function * Allergic constitution, or known allergic history of the drug components of this trial; Or allergic to other monoclonal antibodies * Patients with a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), were not allowed to enter the group; If there is occult blood in the stool (+), gastroscopy is required * Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this trial * Urine protein ≥2+ and 24h urine protein quantitative \> 1.0 g * Patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg)

TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC

NCT07074106
Recruiting
Conditions Breast Cancer
Phase PHASE2
Enrollment 40
Locations 5 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This is a phase II clinical study testing a more personalized and lighter chemotherapy approach for women with stage I or II triple-negative breast cancer. The treatment is adjusted based on signs from the immune system (called tumor-infiltrating lymphocytes, or TILs) and imaging results during treatment. Patients with stage I triple-negative breast cancer (regardless of TIL levels) and those with stage II disease and high TILs (50% or more) will receive a combination of two chemotherapy drugs (carboplatin and a taxane) for four cycles. If imaging shows the tumor has completely disappeared after this treatment, the patient will go straight to surgery. If the tumor is still visible, the treatment will be strengthened with additional chemotherapy drugs (anthracycline and cyclophosphamide), with or without a medicine called pembrolizumab, which helps the immune system fight cancer. The main goal of the study is to see how many patients have a complete disappearance of the cancer after treatment. Other goals include understanding how imaging results relate to what is found during surgery and tracking how long patients live without the cancer coming back.

Design

Study type: Interventional Phases: Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Carboplatin and a Taxane — All patients will receive Carboplatin and a Taxane for 4 cycles. * Patients who achieve a complete radiological response will proceed directly to surgery. * Patients without a complete radiological response will receive Doxorubicin and Cyclophosphamide, with or without Pembrolizumab, for an additional 4 cycles before surgery.

Primary Outcomes

  • Pathological complete response rate after 4 cycles of Carboplatin plus Paclitaxel. (3 mo)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-10-31
Completion: 2028-07-01
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: D'Or Institute for Research and Education
Collaborators: Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
Contact Information
Study Contact:
Intituto D'Or de Pesquisa e Ensino São Paulo
pesquisaclinica@idor.org
oncologia.projetos@idor.org
pesquisaclinica@idor.org
oncologia.projetos@idor.org
Instituto D'Or de Pesquisa e Ensino de Brasília
pesquisaclinica@idor.org
oncologia.projetos@idor.org
Instituto D'Or de Pesquisa e Ensino de Curitiba
Interventions
  • Drug: Carboplatin and a Taxane — All patients will receive Carboplatin and a Taxane for 4 cycles. * Patients who achieve a complete radiological response will proceed directly to surgery. * Patients without a complete radiological response will receive Doxorubicin and Cyclophosphamide, with or without Pembrolizumab, for an additional 4 cycles before surgery.
Study Locations (5 sites)
Instituto D'Or de Pesquisa e Ensino de Brasília, Brasília, Brazil
Instituto D'Or de Pesquisa e Ensino de Curitiba, Curitiba, Brazil
Instituto D'Or de Pesquisa e Ensino do Rio de Janeiro, Rio de Janeiro, Brazil
Instituto D'Or de Pesquisa e Ensino de Salvador, Salvador, Brazil
Instituto D'Or de Pesquisa e Ensino de São Paulo, São Paulo, Brazil
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed primary invasive breast carcinoma. * One of the following conditions: * Clinical stage T1c N0 M0 with any level of TILs; or * Clinical stage T2 N0 M0 with TILs ≥ 50%. * Estrogen receptor (ER) and progesterone receptor (PR) expression \< 10%. * HER2-negative or non-amplified, according to current ASCO-CAP criteria. * No evidence of distant metastasis based on imaging performed prior to study entry (chest/abdomen/pelvis CT scan or FDG PET-CT). * Age ≥ 18 years. * ECOG performance status of 0 to 2. * Adequate organ function Exclusion Criteria: * The subject has an uncontrolled severe concomitant condition, including but not limited to: active or ongoing infection, unstable angina, uncontrolled cardiac arrhythmia, congestive heart failure (NYHA Class III or IV), active ischemic heart disease, or chronic liver or kidney disease. * Pregnant or breastfeeding participants. * History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes.

Breast Cancer Screening Adherence for Women at Moderate Risk for Breast Cancer

NCT07076147
Recruiting
Conditions Breast Carcinoma
Phase Not Applicable
Enrollment 150
Locations 2 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study assesses breast cancer screening adherence for women at moderately increased risk for developing breast cancer based on gene mutation status or empiric risk model estimates. It also seeks to determine facilitators and barriers to screening.

Design

Study type: Observational Observational model: Case Only Time perspective: Cross Sectional

Interventions / Regimen

  • Other: Non-Interventional Study — Non-interventional study

Primary Outcomes

  • Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling (Up to 2 years)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-06-02
Completion: 2028-06-02
Eligibility
Age: 30 Years – 75 Years
Sex: FEMALE
Volunteers: true
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Southern California
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Jacob Comeaux (PRINCIPAL_INVESTIGATOR) - University of Southern California
Contact Information
Study Contact:
Jacob Comeaux
323-865-0474
Jacob.Comeaux@med.usc.edu
Los Angeles General Medical Center
Jacob Comeaux
Los Angeles General Medical Center
Jacob Comeaux
323-865-0474
Jacob.Comeaux@med.usc.edu
USC / Norris Comprehensive Cancer Center
Interventions
  • Other: Non-Interventional Study — Non-interventional study
Study Locations (2 sites)
Los Angeles General Medical Center, Los Angeles, California 90033 United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California 90033 United States
Eligibility Criteria
Inclusion Criteria: * \* \>= 30 years * =\< 75 years * Women with either: * Genetic test results showing moderately increased breast cancer risk due to a pathogenic/likely pathogenic variant in ATM, CHEK2, BARD1, RAD51C, or RAD51D (Mutation carrier group) OR * Calculated lifetime breast cancer risk estimates between 20% and 40% according to the Tyrer-Cuzick V8.0B empiric risk model (Empiric risk group) * Patients provided breast cancer risk assessments by genetic counselors at USC Norris or LA General Hospital beginning in 2021 and at least 12 months ago * Women recommended to undergo annual breast MRI and/or annual mammogram beginning at the time of their genetic counseling risk assessment * English or Spanish speaking patients Exclusion Criteria: * \* History of breast cancer before genetic counseling at University of Southern California (USC) * Any metastatic cancer diagnosis at time of genetic counseling risk assessment * Deceased * Patient underwent a risk reducing mastectomy before their genetic counseling risk assessment

A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors

NCT07383506
Recruiting
Conditions PIK3CA Mutations, Advanced Solid Tumors,...
Phase PHASE1
Enrollment 90
Locations 12 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA mutations

Design

Study type: Interventional Phases: Phase1 Allocation: Non Randomized Intervention model: Sequential Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: CGT6297 — CGT6297 Daily Oral Administration

Primary Outcomes

  • Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1a] (Approximately 12 months)
  • Overall Response Rate [Phase 1b] (Approximately 8 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2026-07-23
Completion: 2029-08
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Cogent Biosciences, Inc.
Contact Information
Study Contact:
Cogent Biosciences, Inc
6179455576
trialinfo@cogentbio.com
Interventions
  • Drug: CGT6297 — CGT6297 Daily Oral Administration
Study Locations (12 sites)
HonorHealth Research Institute, Scottsdale, Arizona 85258 United States
START Los Angeles, Los Angeles, California 90025 United States
Stanford Cancer Center, Palo Alto, California 94304 United States
Sarah Cannon Research Institute (SCRI) at HealthONE-Denver, Denver, Colorado 80218 United States
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc., Tampa, Florida 33612 United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02215 United States
Washington University School of Medicine - Siteman Cancer Center, St Louis, Missouri 63110 United States
START New Jersey, LLC, East Brunswick, New Jersey 08816 United States
SCRI Oncology Partners - Nashville, Nashville, Tennessee 01071 United States
NEXT Austin, Austin, Texas 78758 United States
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and/or tumor: 1. Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer 2. Phase 1b Cohort 2, participants must have HR-positive/HER2-negative or HER2-low breast cancer (immunohistochemistry \[IHC\] and in-situ hybridization results must meet ASCO-College of American Pathology guidelines for breast cancer or criteria) 3. Phase 1b Cohort 3 will allow all solid tumors that do not meet criteria for Phase 1b Cohorts 1 or 2, including head and neck cancers, other gynecological cancers, colorectal cancers harboring PIK3CA mutations 2. Meet prior treatment requirement of: 1. Phase 1a: previously treated with and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition. 2. Phase 1b: previously treated with or considered not appropriate for SOC first-line treatment for their condition 3. Have at least one measurable lesion according to RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits 6. Resolution of acute toxicities from prior anticancer therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities (other than parameters specified in screening testing as outlined below), as determined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE) v5.0. 7. Have an ejection fraction ≥50% Exclusion Criteria: 1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug. 2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug 3. Treatment with radiotherapy ≤2 weeks before the first dose of study drug. 4. Clinically significant cardiac disease 5. Ongoing or planned long-term (≥4 consecutive weeks) treatment with glucocorticoid steroids at greater than physiologic dosing (defined as equivalent to \>20 mg/day prednisone) 6. Diagnosis of diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 (defined as fasting glucose ≥140 mg/dL and HbA1c ≥7.0%; antihyperglycemic medical management permitted with the exception of insulin) 7. Previous molecular testing (NGS or PCR) showed tumor with the following mutations: mutations/deletions in PTEN or activating mutations in AKT, HRAS/KRAS/NRAS, EGFR, and BRAF

Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency

NCT04892693
Recruiting
Conditions Advanced Breast Cancer
Phase PHASE2
Enrollment 70
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

Talazoparib has shown clinical efficacy in breast cancer patients with germline BRCA1 or BRCA2 mutations. Beyond BRCA1 and BRCA2 mutations, it is plausible that talazoparib may have activity in patients with homologous recombination defects (HRD).

Design

Study type: Interventional Phases: Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Talazoparib Oral Capsule — \- Patients will receive Talazoparib 1 mg orally once daily continuously, with or without food. Laboratory values will be monitored every 4 weeks until progression or unacceptable toxicity. Dose modifications should be made based on the observed toxicity

Primary Outcomes

  • Response rate (RR) (Enrollment to end of treatment up to 2 years)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2021-05-25
Completion: 2027-05-31
Eligibility
Age: 19 Years and older
Sex: FEMALE
Volunteers: false
Enrollment: 70 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Seoul National University Hospital
Principal Investigators:
  • Seock-Ah Im, MD, PhD (PRINCIPAL_INVESTIGATOR) - Seoul National University Hospital
Contact Information
Study Contact:
Seock-Ah Im, MD, PhD
82-2-2072-0850
moisa@snu.ac.kr
Yuri Park, RN
82-2-3668-7088
sesame1025@gmail.com
Seock-Ah Im
82-2-2072-0850
moisa@snu.ac.kr
Seoul National University Hospital
Interventions
  • Drug: Talazoparib Oral Capsule — \- Patients will receive Talazoparib 1 mg orally once daily continuously, with or without food. Laboratory values will be monitored every 4 weeks until progression or unacceptable toxicity. Dose modifications should be made based on the observed toxicity
Study Locations (1 sites)
Seoul National University Hospital, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: 1. Adults ≥19 years old. 2. Pathologically documented breast cancer that is unresectable or metastatic 3. Tumor with homologous recombination deficiency (HRD) defined by * Germline or Somatic BRCA1/2 mutation * Homologous recombination repair (HRR) genes mutation * HRD detected through RAD51 foci formation functional assay * HRR genes: ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L 4. Previously treated with a taxane, unless this treatment was contraindicated (whether in recurrent/metastatic setting or in neoadjuvant/adjuvant setting). 5. Previous treatment with platinum therapy in the advanced or metastatic setting is permitted, provided the patient did not have a progression during the platinum treatment. If the patient was treated with neoadjuvant or adjuvant platinum therapy, at least 6 months of disease-free interval is required after the last dose. 6. Documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy). \- If the patients had relapsed within 6 months after adjuvant therapy, this will be counted as a systemic chemotherapy for advanced or metastatic disease. 7. At least 3 weeks has passed since last chemotherapy treatment 8. At least 2 weeks has passed since last hormone therapy or radiation therapy (including palliative radiation). 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 10. At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (magnetic resonance imaging \[MRI\] where CT is not feasible) and is suitable for repeated assessment as per RECIST v.1.1. 11. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7.0 months after the last dose of study treatment. \- This study recommend "Copper T intrauterine device" as a highly effective methods of contraception (\<1% failure rate) 12. Adequate normal organ and marrow function measured within 28 days prior to administration of study treatment * Hemoglobin ≥9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Platelet count ≥ 75 x 109/L * Serum bilirubin ≤ 2.0mg/dL \[This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\] * AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN * Adequate renal function: Serum creatinine ≤1.5mg/dL or estimated creatinine clearance \>60 mL/min 13. Negative urine pregnancy test within 7 days prior to registration in premenopausal patients. 14. Ability to understand and comply with protocol during study period 15. Patients should sign a written informed consent before study entry Exclusion Criteria: 1. Prior treatment PARP inhibitor 2. However, if the patient participated in a clinical trial evaluating adjuvant PARP inhibitor, patient is allowed to be included in the present study if the patient recurred 6 months after completing PARP inhibitor. No more than three line of previous systemic chemotherapy, excluding neo-adjuvant and adjuvant chemotherapy. (No limitation on hormone therapy. Hormone therapy is not counted as previous line) 3. If there is a standard treatment available for metastatic breast cancer. 4. History of another primary malignancy except for * Malignancy treated with curative intent and with no known active disease ≥3 years * contralateral breast cancer * Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease * Adequately treated carcinoma in situ without evidence of disease 5. Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled GI disease (e.g., Crohn's disease, ulcerative colitis) 6. History of leptomeningeal carcinomatosis 7. Brain metastases or spinal cord compression. \- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days 8. active infection or immunocompromised patients including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B , hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). \- Subjects with simple HBV carrier, a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 9. Patients who have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study agents or their excipients. 10. Female patients who are pregnant or breastfeeding. 11. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy

NCT06313463
Recruiting
Conditions Breast Neoplasms
Phase PHASE3
Enrollment 375
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC) who have not achieved pathological complete response (pCR) after neoadjuvant chemotherapy and have tertiary lymphoid structures (TLS) in the tumor tissue. The primary endpoint of this study is disease-free survival (DFS) to assess the long-term effectiveness of the treatment. Secondary endpoints include invasive disease- free survival (IDFS), overall survival (OS), distant recurrence-free interval (DRFI), as well as safety and patient-reported outcomes. These endpoints will comprehensively evaluate the effectiveness of the treatment and the overall survival status of the patients. The study anticipates a total sample size of 375 patients, who will be randomly assigned to either the experimental group or the control group. The experimental group will receive 8 cycles of adjuvant therapy of capecitabine and camrelizumab. The control group will receive 8 cycles of adjuvant therapy with capecitabine and placebo. This study aims to investigate whether non-pcr breast cancer patients with TLS in tumors can benefit from the adjuvant immunotherapy.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Drug: Carrellizumab + Capecitabine — Capecitabine 1000-1250mg/m2 PO bid D1-14（Q3W）+ Carrellizumab 200mg IV D1（Q3W），8 cycles in total
  • Drug: Placebo + Capecitabine — Capecitabine 1000-1250mg/m2 PO bid D1-14（Q3W）+ Placebo 200mg IV D1（Q3W），8 cycles in total

Primary Outcomes

  • Disease-Free Survival (3 years)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2024-03
Completion: 2035-12
Eligibility
Age: 18 Years – 80 Years
Sex: FEMALE
Volunteers: false
Enrollment: 375 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Principal Investigators:
  • Shicheng Su (PRINCIPAL_INVESTIGATOR) - Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Information
Study Contact:
Shicheng Su
+86 13631304227
sushch@mail.sysu.edu.cn
Shicheng Su, M.D., Ph.D.
+86 13632394954
lnl_trial@126.com
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Erwei Song, M.D., Ph.D.
+86 13719237746
lnl_trial@126.com
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Interventions
  • Drug: Carrellizumab + Capecitabine — Capecitabine 1000-1250mg/m2 PO bid D1-14（Q3W）+ Carrellizumab 200mg IV D1（Q3W），8 cycles in total
  • Drug: Placebo + Capecitabine — Capecitabine 1000-1250mg/m2 PO bid D1-14（Q3W）+ Placebo 200mg IV D1（Q3W），8 cycles in total
Study Locations (1 sites)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510120 China
Eligibility Criteria
Inclusion Criteria: * Signed informed consent form. * Female patients aged ≥18 years at the time of signing informed consent. * Patients with adequate cognitive ability and willingness to understand and comply with the treatment and follow-up plans as required by the study protocol. * Confirmed invasive breast cancer on histological examination. * Clinical stage at presentation: cT4/any N/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (patients with cT1mi/T1a/T1b/N0 are not eligible). * Confirmation of TNBC diagnosis and TLS and PD-L1 status through central examination of representative tumor tissue specimens resected during surgery. * Patients with synchronous bilateral invasive disease or multicentric tumors (involving more than one quadrant) are eligible for the study, provided that all discrete lesions are confirmed by the central laboratory as TNBC and TLS-positive. For patients with multifocal tumors (more than one mass involving the same quadrant), sampling must be performed on at least one lesion, confirmed by the central laboratory as TNBC and TLS-positive. * For patients with multifocal or multicentric breast cancer, measurement of the largest lesion to determine the T stage is required. * Confirmation of TNBC and prospective assessment of TLS presence in tumor tissue before study enrollment, confirmed by HE staining and immunofluorescence staining. TLS positivity is defined as the presence of CD3+ and CD20+ cell aggregates identified by HE staining or immunofluorescence staining on tumor tissue or peritumoral tissue sections. * Completion of preoperative systemic chemotherapy and camrelizumab treatment. * Pathological assessment after neoadjuvant treatment did not achieve pCR. * Adequate resection: Complete removal of all clinically evident lesions in the breast and lymph nodes. * Interval between the date of initial surgery and randomization date not exceeding 12 weeks. * Eastern Cooperative Oncology Group performance status score of 0 or 1. * Completion of neoadjuvant therapy with echocardiography or multi-gated acquisition scan showing left ventricular ejection fraction (LVEF) ≥50% during the screening period and an absolute decrease in LVEF compared to pre-chemotherapy LVEF not exceeding 15%. Alternatively, if LVEF assessment was not performed pre-chemotherapy, LVEF must be ≥55% during the screening period post-neoadjuvant therapy. * Life expectancy ≥6 months. * Adequate hematological and organ function. * Negative HIV test result during screening, with the following exceptions: patients with positive HIV test results during screening are eligible to participate in the study, provided they receive stable antiretroviral therapy, have a CD4 count ≥200/µL, undetectable viral load, and no history of AIDS-defining opportunistic infections within 12 months prior to randomization. Investigators should consider potential drug interactions between study treatment and antiretroviral therapy before patient enrollment. * Negative hepatitis B surface antigen (HBsAg) test result during screening. * Negative hepatitis C virus (HCV) antibody test result during screening, or positive HCV antibody test result during screening, followed by negative HCV RNA test result. * For women of childbearing potential: agreement to practice abstinence (no heterosexual intercourse) or use contraception, and agreement not to donate eggs. Exclusion Criteria: * Stage IV (metastatic) breast cancer * Inadequate resection (as described in the inclusion criteria) * At the end of preoperative systemic therapy, the overall response assessment by the researchers resulted in disease progression. * Patients recommended for radiotherapy for breast cancer but contraindicated due to medical reasons (e.g., connective tissue diseases or prior radiation to the ipsilateral breast). * Presence of another malignant tumor within the last 5 years before screening (excluding appropriately treated cervical carcinoma in situ, non-melanoma skin cancer, Stage I endometrial carcinoma, or DCIS). * Prior use of CD137 agonists or immune checkpoint inhibitors, including anti-cytotoxic T-lymphocyte-associated protein 4, anti-PD-1, and anti-PD-L1 therapeutic antibodies. * Current presence of ≥ Grade 2 peripheral neuropathy (according to NCI CTCAE v5.0). * Dyspnea at rest. * Presence of any of cardiopulmonary dysfunction. * Current or past history of autoimmune disease or immunodeficiency. * Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, or history of idiopathic pneumonia or evidence of active pneumonia. * Active tuberculosis. * History of severe, uncontrolled systemic diseases (e.g., clinically significant cardiovascular, pulmonary, or metabolic diseases; impaired wound healing; ulcers). * Known active liver disease, such as autoimmune hepatitis or sclerosing cholangitis. * Receipt of major surgery within 4 weeks before randomization (excluding breast cancer surgery) or anticipated need for major surgery during the study. * Occurrence of severe infection within 4 weeks before randomization, including but not limited to hospitalization due to complications of infection, sepsis, or severe pneumonia, SARS-CoV-2 infection, or any active infection deemed likely to affect patient safety by the investigator. * Receipt of therapeutic antibiotics by intravenous injection within 2 weeks or oral antibiotics within 5 days before randomization. * Previous allogeneic bone marrow or solid organ transplantation. * Contraindication to experimental drugs or any other diseases, metabolic disorders, physical examination findings, or clinical laboratory findings that may affect the interpretation of results or may put the patient at high risk of treatment-related complications. * Receipt of a live attenuated vaccine within 4 weeks before randomization or anticipated need for such a vaccine during the study treatment period or within 5 months after the last dose of treatment. * Receipt of experimental treatment within 28 days before randomization. * Receipt of systemic immunostimulatory agents (including but not limited to interferons and IL-2) within 4 weeks before randomization or within 5 half-lives of the drug (whichever is longer). * Receipt of systemic immunosuppressive medications (including but not limited to corticosteroids, azathioprine, methotrexate, salicylates, and anti-tumor necrosis factor-alpha \[TNF-α\] agents) within 2 weeks before randomization or anticipated need for systemic immunosuppressive medications during the study treatment period. * Previous severe hypersensitivity/allergic reaction to chimeric or humanized antibodies or fusion proteins. * Known severe hypersensitivity to any component of the drug. * Pregnancy or lactation, or planning to become pregnant within 6 months after the end of the study treatment period.

Response-Based Local Therapy for Regionally Advanced Breast Cancer

NCT07376538
Recruiting
Conditions Breast Cancer
Phase PHASE2
Enrollment 157
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this interventional clinical trial is to evaluate if an individualized treatment strategy (involving radiation boost, surgery, and systemic consolidation) can improve progression-free survival in patients with breast cancer presenting with positive ipsilateral supraclavicular (ISLN) and/or internal mammary lymph nodes (IMLN). The main questions it aims to answer are: Is individualized hypofractionated radiotherapy with a local boost safe and effective when adjusted by the response to neoadjuvant treatment? Does local surgery provide benefit for patients who have high residual tumor burden in these lymph nodes after neoadjuvant treatment? How effective is intensified systemic therapy when tailored to the patient's molecular subtype?

Design

Study type: Interventional Phases: Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Radiation: Response-adapted comprehensive treatment strategy — Participants will receive a response-adapted comprehensive treatment strategy following neoadjuvant systemic therapy (NST). The strategy includes: Surgery: Patients with residual ISLN/IMLN ≥ 0.5 cm after NST are assigned (1:1) to receive either regional lymph node dissection or no dissection, in addition to standard breast and axillary surgery. Radiotherapy: Patients receive individualized, dose-adaptive hypofractionated or conventional fractionation radiotherapy guided by the response of the breast and regional nodes to NST. Systemic Therapy: Intensified consolidation systemic therapy is administered based on NST efficacy.

Primary Outcomes

  • Progression-Free Survival (PFS) (Up to 5 years)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-02
Completion: 2033-02
Eligibility
Age: 18 Years – 75 Years
Sex: FEMALE
Volunteers: false
Enrollment: 157 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Information
Study Contact:
Shulian Wang, M.D.
+86-010-87787659
wangsl@cicams.ac.cn
Cancer Hospital, Chinese Academy of Medical Sciences
Interventions
  • Radiation: Response-adapted comprehensive treatment strategy — Participants will receive a response-adapted comprehensive treatment strategy following neoadjuvant systemic therapy (NST). The strategy includes: Surgery: Patients with residual ISLN/IMLN ≥ 0.5 cm after NST are assigned (1:1) to receive either regional lymph node dissection or no dissection, in addition to standard breast and axillary surgery. Radiotherapy: Patients receive individualized, dose-adaptive hypofractionated or conventional fractionation radiotherapy guided by the response of the breast and regional nodes to NST. Systemic Therapy: Intensified consolidation systemic therapy is administered based on NST efficacy.
Study Locations (1 sites)
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality 100021 China
Eligibility Criteria
Inclusion Criteria: Female patients aged 18 to 75 years. ECOG performance status ≤ 2. Histologically confirmed invasive breast cancer. Newly diagnosed breast cancer with pathologically confirmed positive ipsilateral supraclavicular lymph nodes (ISLN) and/or internal mammary lymph nodes (IMLN); for patients in whom IMLN biopsy is not feasible, clinically positive IMLN based on investigator assessment and imaging findings is acceptable. Planned to receive neoadjuvant systemic therapy followed by breast-conserving surgery or mastectomy and axillary lymph node dissection, with or without supraclavicular and/or internal mammary lymph node dissection. Adequate baseline organ function, defined as: absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 9 g/dL (90 g/L); serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min; total bilirubin ≤ 1.5 × ULN; AST and/or ALT ≤ 2.5 × ULN; INR ≤ 1.5 and PT/APTT ≤ 1.5 × ULN. Able and willing to comply with study procedures and scheduled follow-up. Written informed consent obtained prior to any study-related procedures. Exclusion Criteria: Evidence of distant metastatic disease. Presence of severe or uncontrolled concomitant diseases, including severe cardiac dysfunction; myocardial infarction, uncontrolled arrhythmia, or unstable angina within 3 months prior to enrollment; clinically significant pericardial disease; or severe pulmonary disease. Prior radiotherapy to the chest wall or supraclavicular region. Pregnancy, lactation, or any condition considered by the investigator to contraindicate radiotherapy. History of or concurrent second primary malignancy, except for non-melanoma skin cancer, papillary or follicular thyroid carcinoma, carcinoma in situ of the cervix, contralateral non-invasive breast cancer, or other malignancies treated with curative intent with no evidence of disease for more than 3 years.

GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer

NCT05575804
Recruiting
Conditions Advanced/ Metastatic Her-2 Positive Brea...
Phase PHASE1, PHASE2
Enrollment 32
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The aim of this trial is to study the safety, pharmacokinetics and preliminary efficacy of the HER2-targeted antibody-drug conjugate GQ1001 in combination with pyrotinib in patients with HER2-positive metastatic breast cancer patients who had failed previous anti-HER2 treatment.

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: GQ1001+pyrotinib — GQ1001 infusions on day 1 of each 21-day cycle combinate with pyrotinib 320mg orally once daily until disease progression or unacceptable toxicity. I.

Primary Outcomes

  • Dose-limiting toxicities (DLTs), Phase I (From the first dose to the end of Cycle 1, 21 days)
  • Maximum Tolerated Dose (MTD), Phase I (From the first dose to the end of Cycle 1, 21 days)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (up to 24 months)
  • Objective Response Rate (ORR), Confirmed by the researcher's evaluation, Phase II (up to 24 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2022-10-01
Completion: 2028-12-31
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: false
Enrollment: 32 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fudan University
Collaborators: GeneQuantum Healthcare (Suzhou) Co., Ltd.
Contact Information
Study Contact:
Biyun Wang
18017312387
pro_wangbiyun@163.com
Biyun Wang
18017312387
pro_wangbiyun@163.com
Fudan University Shanghai Cancer Center
Interventions
  • Drug: GQ1001+pyrotinib — GQ1001 infusions on day 1 of each 21-day cycle combinate with pyrotinib 320mg orally once daily until disease progression or unacceptable toxicity. I.
Study Locations (1 sites)
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China
Eligibility Criteria
Inclusion Criteria: 1. Having provided written informed consent, and be able to follow clinical trial protocol. 2. Men or women aged 18-75. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1，life expectancy greater than 3 months. 4. Left ventricular ejection fraction (LVEF) ≥50%. 5. Histopathological and/or cytological confirmed Her2-positive locally advanced or metastatic breast cancer (IHC3+, or IHC2+ and ISH+), \*ISH: Fluorescence in situ hybridization (FISH) or dual in situ hybridization (DISH); ISH positivity is defined as a ratio of HER2 gene copy number to CEP17 signal number ≥2.0. When the immunohistochemical (IHC) result is 3+, ISH testing is not required. When the IHC result is 2+, ISH testing should be performed to confirm HER2 positivity. 6. Failure for at least 1 line of standard systemic treatment for metastatic disease. Meet one of the following conditions: 1. Recurrent within 12 months after completing or during neoadjuvant/ adjuvant therapy (the regimens contain trastuzumab or its biosimilar with pertuzumab or not). 2. Received at least one treatment with trastuzumab or its biosimilar ±pertuzumab (monotherapy or in combination with other drugs) for recurrent or metastatic disease. 7. Having at least one measurable lesion according to RECIST 1.1. 8. Previous exposure to taxanes. 9. During the screening period and the first 7 days before treatment, the following indicators confirm appropriate organ functions: 1. Hematology: WBC≥3.0×109/L；NE≥1.5×109/L；Hb≥90 g/L；Plt≥100×109/L; 2. Liver function: Total bilirubin ≤ 1.5 x the upper limit of normal; AST and ALT ≤ 2.5 x the upper limit of normal, ≤ 5.0 x the upper limit of normal in the presence of liver metastases; 3. Kidney function: Serum creatinine ≤1.5 x the upper limit of normal; 4. Coagulation function: prothrombin time and activated partial thromboplastin time ≤1.5 x the upper limit of normal. 10. Adequate wash-out periods: 1. Major surgery ≥4 weeks; 2. Radiotherapy ≥4 weeks (Palliative stereotactic radiotherapy without abdominal involvement radiotherapy: ≥2 weeks); 3. Autologous transplantation: ≥3 months 4. targeted therapy or chemotherapy≥4 weeks; 5. Radioactive particle therapy: ≥3 months 6. Nuclide therapy: ≥3 months 7. Hormone therapy: ≥2 weeks, or based on judgement on the breast cancer 8. Participants from the investigators' judgment; 9. Endocrine therapy: ≥4weeks; 10. Chemotherapy or targeted therapy: 5-fluorouracil-based preparations, folinic acid preparations, and/or Weekly paclitaxel: ≥2 weeks; 11. Tyrosine kinase inhibitor: ≥2 weeks (or 5 half-lives) 12. In the case of a decline period, the longer one shall prevail; 13. Nitrosoureas or mitomycin C: ≥6 weeks 14. Immunotherapy ≥4 weeks; 15. Potent CYP3A4 inhibitor≥3\*t1/2 weeks; 16. Any investigational agents≥4 weeks. 11. Female subjects who are capable of bearing children must have negative urine or serum pregnancy test results within 7 days before randomization, and must commit to using contraception throughout the study period and continue to do so for 7 months after the study ends. Exclusion Criteria: 1. Clinical symptomatic brain metastasis is defined as untreated and symptomatic, or requiring steroid or anticonvulsant treatment to control related symptoms. Patients with asymptomatic brain metastasis, or with stable clinical symptoms and no need for steroid hormone and other treatments for brain metastasis for ≥28 days, can be enrolled. 2. Have previously been treated with: another antibody-drug conjugate (ADC) consisting of DM1 or its derivative，pyrotinib and capecitabine，except for the following situations: 1. During (neo)adjuvant therapy, received pyrotinib, and the participants who have experienced recurrence or metastasis more than 6 months after the last treatment and have not received pirlotinib since then are allowed to be enrolled; 2. Participants who have received pirlotinib treatment during the recurrent and metastatic stage, discontinued the medication due to reasons other than disease progression, and have progressed more than 6 months after discontinuation are allowed to be enrolled; 3. Participants who have received treatment with ADC drugs with different small molecule toxins (such as DS-8201, GQ1005, SHR-A1811, etc.) are eligible for enrollment. Such patients are also allowed to have received pirlotinib treatment during the recurrent or metastatic stage, and those who have progressed after more than 6 months of pirlotinib treatment are also eligible for enrollment. 3. Have other malignant tumors within 5 years before signing the informed consent form ( except for cured skin basal cell carcinoma and cervical carcinoma in situ). 4. Have a medical history of myocardial infarction or clinically significant heart diseases, including but not limited to, 1. symptomatic congestive heart failure (CHF) (NYHA classes II-IV), or serious cardiac arrhythmia which required to therapy; 2. Having a history of myocardial infarction or unstable angina pectoris within 6 months prior to the initial treatment, 3. Have a corrected QT interval (QTc) prolongation to \> 450 milliseconds (ms) in males and \> 470 ms in females. 5. Have clinically significant acute and chronic pulmonary diseases (e.g. interstitial lung disease (ILD), lung infection, pulmonary fibrosis, and severe radiation pneumonitis), participants with a history of ILD/non-infectious pneumonia requiring hormone therapy, or suspected of having lung diseases based on imaging examination at screening, with imaging suggesting miliary disseminated metastasis, subjects with specific pulmonary complications including but not limited to any potential lung diseases (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, or other conditions that may interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to enrollment in the study), or subjects requiring oxygen therapy. 6. History of allergic reaction to any component of GQ1001. 7. The toxicity of previous anti-cancer therapy has not recovered to ≤1 as specified in CTCAE v5.0 (except for hair loss); e.g. chronic grade 2 toxicity might be determined per the investigator's judgment. 8. The cumulative dose of anthracyclines or equivalent\>500 mg/m2. 9. Uncontrollable infections require intravenous antibiotics, antiviral drugs, or antifungal drugs. 10. Hepatitis B virus (HBV) infection (including hepatitis B surface antigen \[HBsAg\] positive or hepatitis B core antibody \[HBcAb\] positive and HBV DNA positive); HIV, syphilis, hepatitis C antibody positive, or other severe and fatal viral or bacterial diseases, except for patients with stable hepatitis B (HBV viral copy number below the upper limit of reference value) after drug treatment and cured hepatitis C patients (HCV viral copy number below the detection limit of assay method). 11. Per the investigator's judgment, participants with any history or current evidence of concomitant disease treatment or laboratory abnormalities may interfere with the trial results, as well as their participation and compliance. 12. Lactating women or women who have confirmed pregnancy through a pregnancy test within 7 days prior to their first treatment. 13. Male or female subjects unwilling to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) during the study and for 7 months following the last dose of the study drug infusion. 14. Other circumstances that are deemed not appropriate for the study. 15. Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug administration and absorption.

PrOspEctive Metastases Imaging (POEM)

NCT07781306
Recruiting
Conditions Liver Metastases, Colorectal Cancer, Bre...
Phase Not Applicable
Enrollment 50
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This is a non-interventional, observational study with an optional interventional biobanking activity. Liver metastases of patients undergoing partial hepatectomy will be sampled completely while respecting the orientation used for medical imaging, in order to correlate the histopathological growth patterns in a 3D-map with the imaging characteristics. The full pathological sampling will only use remnant tissue.

Design

Study type: Observational Observational model: Other Time perspective: Prospective

Primary Outcomes

  • Radiomics Analysis Pipeline The imaging analysis has been designed to predict the continuous proportion and spatial distribution of HGPs (7 years)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2020-09-08
Completion: 2028-05
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Cancer Research Antwerp
Contact Information
Study Contact:
Peter Vermeulen, MD, PhD
0032493194745
peter.vermeulen@zas.be
Emily Latacz, MD
0032476547112
emily.latacz@zas.be
Peter Vermeulen, MD
0032493194745
peter.vermeulen@zas.be
GZA St Augustinus
Interventions
N/A
Study Locations (1 sites)
GZA St Augustinus, Wilrijk, Antwerp 2610 Belgium
Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years old. 2. Patients with liver metastatic colorectal or breast carcinoma undergoing a surgical excision of the liver metastases 3. Therapy-naive patients as well as patients with neo-adjuvant therapy are eligible for inclusion 4. Willingness of the patient to participate in this study demonstrated by signed written informed consent Exclusion Criteria: 1. Patients without MRI or CT of the liver prior to surgery 2. Time interval between medical imaging, CT and/or MRI is more than 12 weeks (nb: time interval is preferably less than 4 weeks but this is not an exclusion criterium) 3. Prior radiofrequency ablation (RFA) or transarterial chemoembolization (TACE) on the liver metastasis that would be operated

PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan

NCT05573893
Recruiting
Conditions Breast Neoplasms, Breast Cancer, Neoplas...
Phase Not Applicable
Enrollment 800
Locations 109 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Real-world Time To Next Treatment (rwTTNT1) (From first dose of T-DXd until initiation of subsequent therapy or death of any cause, whichever came first, assessed up to 60 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2023-09-12
Completion: 2031-12-31
Eligibility
Age: 18 Years – 130 Years
Sex: ALL
Volunteers: false
Enrollment: 800 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Collaborators: Daiichi Sankyo
Contact Information
Study Contact:
AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
Interventions
N/A
Study Locations (109 sites)
Research Site, Amberg, 92224 Germany
Research Site, Ansbach, 91522 Germany
Research Site, Apolda, 99510 Germany
Research Site, Aschaffenburg, 63739 Germany
Research Site, Augsburg, 86150 Germany
Research Site, Augsburg, 86156 Germany
Research Site, Bad Reichenhall, 83435 Germany
Research Site, Baden-Baden, 76532 Germany
Research Site, Balingen, 72336 Germany
Research Site, Bamberg, 96049 Germany
Eligibility Criteria
Inclusion Criteria: 1. Adults ≥ 18 years old 2. Patients (irrespective of sex and gender) with pathologically documented breast cancer that: * is unresectable or metastatic * has confirmed HER2+, HER2-low or HER2-ultralow tumor status by local pathology * was previously treated with one or more anti-HER2 directed therapy if the tumor is HER2+ OR * was previously treated with at least one endocrine therapy in the metastatic setting and is not considered suitable for endocrine therapy as the next line of treatment if the tumor is HR+, HER2-low or HER2-ultralow OR * was previously treated with prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy if the tumor is HER2-low. 3. Has documented radiologic progression (during or after most recent treatment) 4. Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd treatment \* 5. Patient is able to read and understand either German or English 6. Signed written informed consent * The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS. Exclusion Criteria: 1. Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date) 2. Known hypersensitivity to T-DXd or any of the excipients of the drug 3. Pregnancy or breast feeding 4. Current or planned participation in an interventional clinical trial 5. Current or planned systemic treatment of any tumor other than unresectable or metastatic BC Patients who have never received any T-DXd dose will be discontinued from the study and will be considered as a late screening failure, no further documentation besides reason and date of discontinuation is needed.