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Showing 12 of 4196 trials

Efficacy and Safety of HUC3-637 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

NCT07335211
Recruiting
Conditions Primary Open Angle Glaucoma (POAG), Ocul...
Phase PHASE3
Enrollment 206
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
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Study Details Design, interventions, and primary outcomes

About This Study

A multicenter, randomized, single-blind, active controlled, phase III clinical trial to evaluate the efficacy and safety of HUC3-637 in patients with primary open angle glaucoma or ocular hypertension

Design

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

Interventions / Regimen

  • Drug: HUC3-637 — Ophthalmic solution instilled directly into the eye (topical ocular administration)
  • Drug: HUC3-637-R — Ophthalmic solution instilled directly into the eye (topical ocular administration)

Primary Outcomes

  • Mean change in diurnal IOP (12 week)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2026-01
Completion: 2027-12
Eligibility
Age: 19 Years and older
Sex: ALL
Volunteers: false
Enrollment: 206 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Huons Co., Ltd.
Contact Information
Study Contact:
Rang Lee
07074926091
rlee@huons.com
Interventions
  • Drug: HUC3-637 — Ophthalmic solution instilled directly into the eye (topical ocular administration)
  • Drug: HUC3-637-R — Ophthalmic solution instilled directly into the eye (topical ocular administration)
Study Locations (1 sites)
Kangbuk Samsung Hospital, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: * Adults aged 19 years and older * Participants diagnosed with POAG or OH * Have fully explained and understood the study and have voluntarily given written informed consent. Exclusion Criteria: * Acute or chronic angle-closure glaucoma * Congenital glaucoma, secondary glaucoma (open-angle glaucoma)

Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis

NCT06556407
Recruiting
Conditions Treatment Resistant Hypertension, Chroni...
Phase NA
Enrollment 12
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
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Study Details Design, interventions, and primary outcomes

About This Study

The RDN-HD Study is a prospective, single-center feasibility study. All patients included will undergo endovascular ultrasound-based RDN (no sham group, no blinding). The purpose of the RDN-HD Study is to demonstrate that ultrasound-based RDN is safe in patients with TRH and ESRD hemodialysis and reduces 24-h ambulatory BP.

Design

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

Interventions / Regimen

  • Device: renal denervation — ultrasound based renal denervation

Primary Outcomes

  • Safety endpoints and adverse effects (during 6 months post-procedure)
  • Change in 24-h ambulatory systolic blood pressure between baseline and 3 months post-procedure (baseline and 3 months post-procedure)
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-03-04
Completion: 2026-12-01
Eligibility
Age: 18 Years – 99 Years
Sex: ALL
Volunteers: false
Enrollment: 12 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Erlangen-Nürnberg Medical School
Contact Information
Study Contact:
Agnes Bosch, MD
+49 9131 8536207
agnes.bosch@uk-erlangen.de
Roland E. Schmieder, MD
+499131 8536207
roland.schmieder@uk-erlangen.de
Agnes Bosch, MD
+49 9131 8536216
agnes.bosch@uk-erlangen.de
Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension
Interventions
  • Device: renal denervation — ultrasound based renal denervation
Study Locations (1 sites)
Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension, Erlangen, Bavaria 91054 Germany
Eligibility Criteria
Inclusion Criteria: * Uncontrolled treatment resistant hypertension (despite intake of 3 different classes of antihypertensive medications) confirmed by 24-h ambulatory blood pressure according to current guidelines (ESH 2023) (office blood pressure ≥ 140/ and/ or ≥ 90 mmHg and ambulatory blood pressure ≥ 130/ and/or ≥ 80 mmHg * end-stage renal disease on chronic hemodialysis * Stable hemodialysis regime for at least 3 months based on the decision of the treating physician * Patient is adhering to a stable drug regimen without changes for a minimum of 4 weeks. * Individual is ≥ 18 years of age, male and female patients are included. Exclusion Criteria: * Episodes of sustained systolic and/or diastolic hypotension according to 24-h ambulatory blood pressure or dialysis protocols which in the eyes of the treating physician would interfere with a safe renal denervation treatment of the patient * Known hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which in the eyes of the interventionalist would interfere with safe catheter placement * Prior renal denervation procedure * Anatomic or functional solitary kidney, kidney transplantation * Severe atherosclerotic disease or artery calcification preventing the assessment of reliable BP measurements * Endocrine hypertension other than obstructive sleep apnea * Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit * Acute episode of systemic and renal disease requiring uptitration of any immunosuppressive drug regimen within the last 3 months * Subject is pregnant, nursing, or intends to become pregnant * Enrollment in another interventional research protocol. * Any condition that, at the discretion of the investigator, would preclude participation in the study (e.g. non-adherence)

Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization

NCT07224906
Recruiting
Conditions Pulmonary Hypertension, Congestive Heart...
Phase Not Applicable
Enrollment 50
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
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Study Details Design, interventions, and primary outcomes

About This Study

The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures.

Design

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

Primary Outcomes

  • Association between device measurements and Pulmonary Capillary Wedge Pressure (Day 1)
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-12-01
Completion: 2027-01
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: HemoCept Inc.
Contact Information
Study Contact:
Katharine Adkins
303-442-2395
kathari.adkins@bch.org
Katharine Adkins
303-442-2395
kathari.adkins@bch.org
Boulder Heart
Scott Blois, MD
Boulder Heart
Interventions
N/A
Study Locations (1 sites)
Boulder Heart, Boulder, Colorado 80303 United States
Eligibility Criteria
Inclusion Criteria: * Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures. * Subjects can be any gender but must be age 18 or older. * Subject is able and willing to provide informed consent and HIPAA authorization. * Subject is able and willing to meet all study requirements. * Scheduled for a diagnostic right heart catheterization (RHC-only or combined RHC+LHC; left-heart-only procedures are not eligible) Exclusion Criteria: * Subject is pregnant, breastfeeding, or intends to become pregnant during this study.

The Use of Combined Motor Imagery and Action Observation to Evaluate the Influence on Functional Parameters Such as Strength, Range of Motion, Pain or Fear of Movement Among Others, in Females Breast Cancer Survivors.

NCT07067710
Recruiting
Conditions Breast Cancer Survivor
Phase NA
Enrollment 108
Locations 3 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
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Study Details Design, interventions, and primary outcomes

About This Study

The aim of this study is to evaluate the effectivity of the combined motor imagery and action observation therapies to improve functional parameters such as strenght, range of motion, pain or fear of movements among others in relation to upper limb in breast cancer survivors. The main question it aims to answer is: Will a combined therapy of motor imagery and action observation improve the strenght, rang of motion, pain, limb diameter and fear of movement of the upper limb in breast cancer survivor females? The participants will be part of the IM-OA23 proyect that consist on seeing some diferent videos about upper limb mobility and then they'll have to imagine the movements and to performed themselves. Researches will compare two groups (control group and intervention group) to evaluate the diferences between them.

Design

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

Interventions / Regimen

  • Other: Motor imagery combined with action observation — To observe and imaging one action with a video resource. Not virtual reality.

Primary Outcomes

  • Sthrength (From enrollement to the end of the treatment at 6 weeks and 3 month after)
  • Range of Motion (From enrollement to the end of the treatment at 6 weeks and 3 month after)
  • Pain intensity (From enrollement to the end of the treatment at 6 weeks and 3 month after)
  • Limb diameter (From enrollement to the end of the treatment at 6 weeks and 3 month after)
  • Fear of movement (From enrollement to the end of the treatment at 6 weeks and 3 month after)
  • Imagery (From enrollement to the end of the treatment at 6 weeks and 3 month after)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-02-25
Completion: 2026-02
Eligibility
Age: 18 Years and older
Sex: FEMALE
Volunteers: false
Enrollment: 108 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fundacion Miguel Servet
Collaborators: Fundación Instituto de Investigación Sanitaria de Navarra
Principal Investigators:
  • Paula Escalada-Hernández, PhD (STUDY_DIRECTOR) - Public University of Navarra
  • Nelia Soto-Ruiz, PhD (STUDY_DIRECTOR) - Universidad Pública de Navarra
  • Pilar Arnal-Vallés, Candidate PhD (PRINCIPAL_INVESTIGATOR) - Hospital of Navarra
Contact Information
Study Contact:
Pilar Arnal-Vallés, Candidate PhD
+34 948166117
pilararnal3b@gmail.com
Pilar Arnal-Vallés, Candidate PhD
+34 948166117
pilararnal3b@gmail.com
Public University of Navarre
Paula Escalada-Hernández, PhD
Public University of Navarre
Interventions
  • Other: Motor imagery combined with action observation — To observe and imaging one action with a video resource. Not virtual reality.
Study Locations (3 sites)
Public University of Navarre, Pamplona, Navarre 31008 Spain
Public University of Navarre, Pamplona, Navarre 31008 Spain
Public University of Navarre, Pamplona, Navarre 31008 Spain
Eligibility Criteria
Inclusion Criteria: * Female, over 18 years, have suffered breast cancer, have ended active treatments (chemotherapy, radiotherapy, surgery), have pain or functional limitation or lymphedema at upper limb afected. Exclusion Criteria: * males, people with active treatments ongoning, other types of cancer, recurrence or metastasis of cancer

Dermatitis During Adjuvant Irradiation for BREAst Cancer:

NCT06483477
Recruiting
Conditions Breast Cancer Female
Phase NA
Enrollment 268
Locations 5 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
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Study Details Design, interventions, and primary outcomes

About This Study

In the randomized DAI-BREAC trial, a reminder app will be prospectively tested that reminds breast cancer patients four times each day to perform the required skin care. This will likely contribute to the reduction of grade ≥2 radiation dermatitis in these patients. A total of 268 patients will be randomized to receive standard skin care supported by a reminder app (Arm A) or standard skin care alone (Arm B). Stratification will be done using the three factors treatment volume, radiation boost, and at least one risk factor of dermatitis. Secondary aims include pain (radiation fields), patient satisfaction with the reminder app (Arm A only), impact of the app on the use of health technology (Arm A only), and benefit from support by staff members of the treating Department of Radiation Oncology and/or the UKSH academy regarding the use of the app (Arm A only).

Design

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

Interventions / Regimen

  • Other: Standard skin care — From the start of radiotherapy, standard skin care has to be performed by the patient. This may vary at the participating centers. At the site in Lübeck, it includes fatty cream with 2-10% urea (fatty cream alone, if patients do not tolerate urea) and, in case of pruritus, addition of mometasone furoate cream. In case of grade ≥2 moist desquamation or grade ≥3 radiation dermatitis, each day antiseptic agents will be administered for wound cleansing followed by administration of silicon or calcium alginate bandage. This treatment will be continued until moist desquamation radiation disappears and radiation dermatitis improves to grade 2. Fatty cream with 2-10% urea is applied to the irradiated skin four times daily. Mometasone furoate cream: In addition to the fatty cream with 2-10% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
  • Device: Reminder App — In addition to standard skin care, patients are supported by a Reminder App. The purpose of the app is to remind the patients in an intuitive, unobtrusive and supportive way to perform skin care. By default, patients are reminded four times a day, but they will also be able to define a notification schedule that best suits their personal needs. The patients may postpone each required care procedure for up to 2 hours. With each procedure, the patients are guided through the skin care with simple and self-explanatory illustrations. To increase the patients' motivation, they will additionally earn points for regular and punctual performed care procedures. The patients receive a hand-out including instructions how to properly perform skin care, but they can also find an information page within the application that includes similar instructions.

Primary Outcomes

  • Prevention of grade ≥2 radiation dermatitis (through study completion, an average of 4 weeks)
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-12-23
Completion: 2026-09-30
Eligibility
Age: 18 Years and older
Sex: FEMALE
Volunteers: false
Enrollment: 268 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital Schleswig-Holstein
Collaborators: University of Southern Denmark, Medical School Hamburg
Principal Investigators:
  • Dirk Rades, MD, FASTRO (PRINCIPAL_INVESTIGATOR) - Dept. of Radiation Oncology, University of Lubeck, Germany
Contact Information
Study Contact:
Dirk Rades, MD, FASTRO
0049-451-500
DIRK.RADES@UKSH.DE
Carlos A. Narvaez-Wolf, MD
0049-451-500
Carlos.Narvaez-Wolf@uksh.de
Charlotte Kristiansen, MD
0045-7940
charlotte.kristiansen@rsyd.dk
Vejle Hospital, University Hospital of Southern Denmark
Interventions
  • Other: Standard skin care — From the start of radiotherapy, standard skin care has to be performed by the patient. This may vary at the participating centers. At the site in Lübeck, it includes fatty cream with 2-10% urea (fatty cream alone, if patients do not tolerate urea) and, in case of pruritus, addition of mometasone furoate cream. In case of grade ≥2 moist desquamation or grade ≥3 radiation dermatitis, each day antiseptic agents will be administered for wound cleansing followed by administration of silicon or calcium alginate bandage. This treatment will be continued until moist desquamation radiation disappears and radiation dermatitis improves to grade 2. Fatty cream with 2-10% urea is applied to the irradiated skin four times daily. Mometasone furoate cream: In addition to the fatty cream with 2-10% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
  • Device: Reminder App — In addition to standard skin care, patients are supported by a Reminder App. The purpose of the app is to remind the patients in an intuitive, unobtrusive and supportive way to perform skin care. By default, patients are reminded four times a day, but they will also be able to define a notification schedule that best suits their personal needs. The patients may postpone each required care procedure for up to 2 hours. With each procedure, the patients are guided through the skin care with simple and self-explanatory illustrations. To increase the patients' motivation, they will additionally earn points for regular and punctual performed care procedures. The patients receive a hand-out including instructions how to properly perform skin care, but they can also find an information page within the application that includes similar instructions.
Study Locations (5 sites)
Vejle Hospital, University Hospital of Southern Denmark, Vejle, Southern Denmark 7100 Denmark
Medical Practice for Radiotherapy and Radiation Oncology, Hanover, Lower Saxony 30161 Germany
Medical School Hamburg, Schwerin Campus, Schwerin, Mecklenburg-Vorpommern 19055 Germany
Malteser Hospital St. Franziskus, Flensburg, Schleswig-Holstein 24939 Germany
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Lübeck, 23562 Germany
Eligibility Criteria
Inclusion Criteria: 1. Histologically proven invasive breast cancer 2. Indication for adjuvant hypo-fractionated radiotherapy 3. Possession of and ability to use a smartphone 4. Female gender 5. Age ≥18 years 6. Written informed consent 7. Capacity of the patient to contract Exclusion Criteria: 1. Pregnancy, Lactation 2. Expected non-compliance

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

NCT06134375
Recruiting
Conditions Triple Negative Breast Cancer, Residual ...
Phase PHASE1, PHASE2
Enrollment 204
Locations 3 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

There are two parts to this study. It is a phase 1b followed by a randomized phase 2 study to assess whether adding 3 years of adjuvant tetrathiomolybdate (TM) to standard 6 months treatment of adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer. In the phase 1b part of the study, TM is added to adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer (RCB 2, 3, risk for relapse \>60% at 5 years) after completion of neoadjuvant chemo-immunotherapy and surgery to establish the safety of the combination. This will be followed by a randomized phase 2 clinical trial of adjuvant TM and capecitabine vs capecitabine alone. If pembrolizumab was administered in the neoadjuvant setting, it may be continued in the adjuvant setting per investigator discretion.

Design

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

Interventions / Regimen

  • Drug: Tetrathiomolybdate — Tetrathiomolybdate (TM): Ammonium tetrathiomolybdate (TM), an oral copper lowering agent, has been established as safe in patients with Wilson's disease and advanced cancer. TM forms stable copper-molybdenum clusters sequestering copper and thereby limiting its availability, for the proper functioning of angiogenic factors, including secreted metalloenzymes. TM inhibits several copper containing enzymes including ceruloplasmin, cytochrome oxidase, tyrosinase and downregulates cytokines such as MMP9 and VEGF as well as transcription factors such as NF-kB. Both pre-clinical and clinical data suggest that TM may effectively reduce both overt and sub-clinical tumor load by both targeting the metastases initiating stem cell component of primary tumors inactivating Complex IV, shifting oxphos to glycolysis and through stromal remodeling.
  • Drug: Capecitabine — 1000mg/m2 twice daily, Days 1-14 Q21days for 6 months
  • Drug: Pembrolizumab — If pembrolizumab was administered in the neoadjuvant setting and the oncology team chooses to continue in the adjuvant setting, standard doses will be used (200 mg IV Q3weeks or 400 mg IV Q6 weeks for one year total as per package insert)

Primary Outcomes

  • Phase 1b: To establish the safety of the combination of adjuvant tetrathiomolybdate with capecitabine and pembrolizumab by the number of dose limiting toxicities (3 years)
  • Phase 2: Distant relapse-free survival (DRFS) between TM and capecitabine versus capecitabine as measured with the STEEP system (10 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: PHASE1, PHASE2
Status: Recruiting
Start Date: 2024-11-26
Completion: 2036-06-26
Eligibility
Age: 18 Years – 80 Years
Sex: ALL
Volunteers: false
Enrollment: 204 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Dartmouth-Hitchcock Medical Center
Collaborators: National Cancer Institute (NCI), Congressionally Directed Medical Research Programs
Principal Investigators:
  • Linda Vahdat, MD (PRINCIPAL_INVESTIGATOR) - Study Principal Investigator
Contact Information
Study Contact:
Raven J Lavoie, RN
(603) 653-3661
Raven.M.Lavoie@hitchcock.org
Naomi Kornhauser, MPH
naomi.t.kornhauser@hitchcock.org
Bryan Schneider, MD
Indiana University Simon Cancer Center
Interventions
  • Drug: Tetrathiomolybdate — Tetrathiomolybdate (TM): Ammonium tetrathiomolybdate (TM), an oral copper lowering agent, has been established as safe in patients with Wilson's disease and advanced cancer. TM forms stable copper-molybdenum clusters sequestering copper and thereby limiting its availability, for the proper functioning of angiogenic factors, including secreted metalloenzymes. TM inhibits several copper containing enzymes including ceruloplasmin, cytochrome oxidase, tyrosinase and downregulates cytokines such as MMP9 and VEGF as well as transcription factors such as NF-kB. Both pre-clinical and clinical data suggest that TM may effectively reduce both overt and sub-clinical tumor load by both targeting the metastases initiating stem cell component of primary tumors inactivating Complex IV, shifting oxphos to glycolysis and through stromal remodeling.
  • Drug: Capecitabine — 1000mg/m2 twice daily, Days 1-14 Q21days for 6 months
  • Drug: Pembrolizumab — If pembrolizumab was administered in the neoadjuvant setting and the oncology team chooses to continue in the adjuvant setting, standard doses will be used (200 mg IV Q3weeks or 400 mg IV Q6 weeks for one year total as per package insert)
Study Locations (3 sites)
Indiana University Simon Cancer Center, Indianapolis, Indiana 46202 United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756 United States
NYU Langone perimutter Cancer Center, New York, New York 10016 United States
Eligibility Criteria
Inclusion Criteria: 1. Patients must have histologically confirmed breast malignancy that is Triple negative tumors as defined as ER and PR \<1% and HER2 negative as per ASCO/CAP guidelines 2. The patient must have completed standard neoadjuvant chemotherapy which constitutes at least 6 cycles of chemotherapy. 3. Phase Ib: Patients must have residual invasive carcinoma, at minimum in one of the following capacities: (1) node positive disease after treatment without residual invasive carcinoma in the breast; (2) RCB 2 or RCB 3 MDAH Calculator; Standard therapy consists of the following: (1) Local therapy: (a) Lumpectomy or mastectomy to negative margins. (b) Sentinel lymph node biopsy or axillary node dissection; (c) Radiation therapy to breast if patient received a lumpectomy and per investigator choice if considering chest wall/extended field RT. (2) Systemic therapy: Prior chemotherapy is required for patients entered on the trial. Neoadjuvant treatment should consist of the following standard therapy: Anthracycline and taxane-based therapy (i.e. AC-\>T, AC-\>Tcarbo, Keynote 522 regimen) or a non-anthracycline based chemo and immunotherapy regimen (NeoPACT). Patients must have received neoadjuvant Pembrolizumab for the phase Ib only and plan to continue it in the adjuvant setting for at least the first cycle of treatment. Randomized Phase 2: Patients must have residual invasive carcinoma, at minimum in one of the following capacities: (1) node positive disease after treatment without residual invasive carcinoma in the breast; (2) RCB 2 or RCB 3 MDAH Calculator; Standard therapy consists of the following: (1) Local therapy: (a) Lumpectomy or mastectomy to negative margins. (b) Sentinel lymph node biopsy or axillary node dissection; (c) Radiation therapy to breast if patient received a lumpectomy and per investigator choice if considering chest wall/extended field RT. (2) Systemic therapy: Prior chemotherapy is required for patients entered on the trial. Neoadjuvant treatment should consist of the following standard therapy: Anthracycline and taxane-based therapy (i.e. AC-\>T, AC-\>Tcarbo, Keynote 522 regimen) or a non-anthracycline based chemo and immunotherapy regimen (NeoPACT). Pembrolizumab is allowed. Patients will be stratified by: (1) Treatment (chemotherapy vs chemotherapy + immunotherapy); (2) Age (Age ≤ 40 yrs vs \> 40 yrs); and (3) RCB 2 vs RCB 3. These important stratification factors represent variables that are known to affect outcome for patients with TNBC. 4. At least two weeks must have elapsed from last chemotherapy or radiation therapy. At least 4 weeks must have elapsed from most recent surgery. 5. No clinical or radiologic evidence of disease after surgery and/or systemic treatment (by CT scan of chest, abdomen and pelvis and bone scan or PET scan prior to enrollment). 6. Previous treatment with capecitabine is not allowed. 7. Because no dosing or adverse event data are currently available on the use of TM in patients \<18 years of age, children are excluded from this study. 8. KPS 90 or 100. 9. Life expectancy of greater than 3 months. 10. Patients must have normal organ and marrow function as defined below: * hemoglobin \>10mg/dL * absolute neutrophil count \>1,500/ µL * platelets \>100,000/µL * total bilirubin \<1.5 x normal institutional limits * AST (SGOT)/ALT (SGPT) \<1.5 X institutional upper limit of normal 11. Antiresorptive therapy and denosumab may be administered. 12. Patients must be on stable medical therapy for at least 2 weeks if they are being treated medically for their chemotherapy induced peripheral neuropathy. 13. The effects of TM on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 14. Ability to understand and the willingness to sign a written informed consent document. 15. Normal B12 levels. Exclusion Criteria: 1. Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study. Patients who have had surgery within 4 weeks. 2. Patients who have received capecitabine or who are on warfarin 3. Patients who had their final breast surgery more than 12 weeks prior to study start. 4. Phase Ib: patients who have not received neoadjuvant immunotherapy and/or do not plan to continue treatment with immunotherapy for at least the first cycle of study treatment. 5. Objective evidence of breast cancer. 6. Metastatic disease 7. Carcinomatous meningitis or active parenchymal brain metastases. 8. Estimated creatinine clearance \< 60 ml/min 9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to TM or capecitabine. 10. Pregnant women are excluded from this study because TM has the potential to have teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TM, breastfeeding should be discontinued if the mother is treated with TM. 11. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti- retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with TM.

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

NCT06841354
Recruiting
Conditions Triple Negative Breast Neoplasms
Phase PHASE3
Enrollment 1000
Locations 285 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Design

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

Interventions / Regimen

  • Biological: Sacituzumab tirumotecan — IV Infusion
  • Biological: Pembrolizumab — IV Infusion
  • Drug: Rescue Medication — Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).
  • Drug: Paclitaxel — IV Infusion
  • Drug: Nab-paclitaxel — IV Infusion
  • Drug: Gemcitabine — IV Infusion
  • Drug: Carboplatin — IV Infusion

Primary Outcomes

  • Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC) (Up to ~39 months)
  • Overall Survival (OS) (sac-TMT versus TPC) (Up to ~61 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: PHASE3
Status: Recruiting
Start Date: 2025-03-16
Completion: 2030-05-18
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Merck Sharp & Dohme LLC
Principal Investigators:
  • Medical Director (STUDY_DIRECTOR) - Merck Sharp & Dohme LLC
Contact Information
Study Contact:
Toll Free Number
1-888-577-8839
Trialsites@msd.com
Study Coordinator
251-410-4924
USA Mitchell Cancer Institute ( Site 0090)
Study Coordinator
623-312-3000
Ironwood Cancer & Research Centers ( Site 0036)
Interventions
  • Biological: Sacituzumab tirumotecan — IV Infusion
  • Biological: Pembrolizumab — IV Infusion
  • Drug: Rescue Medication — Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).
  • Drug: Paclitaxel — IV Infusion
  • Drug: Nab-paclitaxel — IV Infusion
Study Locations (285 sites)
USA Mitchell Cancer Institute ( Site 0090), Mobile, Alabama 36604 United States
Ironwood Cancer & Research Centers ( Site 0036), Chandler, Arizona 85224 United States
City of Hope ( Site 0097), Duarte, California 91010 United States
City of Hope Lennar Foundation Cancer Center ( Site 0099), Irvine, California 92618 United States
UCLA Department of Medicine - Hematology & Oncology ( Site 0047), Los Angeles, California 90095 United States
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016), San Francisco, California 94158 United States
Yale New Haven Hospital ( Site 0001), New Haven, Connecticut 06520 United States
Washington Hospital Center ( Site 0098), Washington D.C., District of Columbia 20010-2975 United States
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007), Altamonte Springs, Florida 32701 United States
Orlando Health Cancer Institute ( Site 0012), Orlando, Florida 32806 United States
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent * Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer * Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence * Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has breast cancer amenable to treatment with curative intent * Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10 * Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer * Has Grade ≥2 peripheral neuropathy * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has skin only metastatic disease * Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications * Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has known additional malignancy that is progressing or has required active treatment within the past 5 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable * Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments * Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection * History of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications

Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence

NCT06430541
Recruiting
Conditions Breast Cancer, Ovarian Cancer
Phase PHASE1
Enrollment 20
Locations 2 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.

Design

Study type: Interventional Phases: Phase1 Allocation: Intervention model: Single Group Primary purpose: Supportive Care Masking/blinding: None

Interventions / Regimen

  • Drug: Psilocybin — A tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors.

Primary Outcomes

  • Change in Fear of Cancer Recurrence Inventory (1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks.)
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: 2024-11-21
Completion: 2028-12
Eligibility
Age: 21 Years and older
Sex: FEMALE
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Denver
Collaborators: Usona Institute
Principal Investigators:
  • Stacy Fischer, MD (PRINCIPAL_INVESTIGATOR) - University of Colorado, Denver
Contact Information
Study Contact:
Mary Mancuso
303-724-5729
mary.mancuso@cuanschutz.edu
Stacy Fischer, MD
Outpatient CTRC
Stacy Fischer, MD
303-724-2406
stacy.fischer@cuanschutz.edu
University of Colorado Cancer Center
Interventions
  • Drug: Psilocybin — A tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors.
Study Locations (2 sites)
Outpatient CTRC, Aurora, Colorado 80045 United States
University of Colorado Cancer Center, Aurora, Colorado 80045 United States
Eligibility Criteria
Inclusion Criteria: 1, Aged ≥ 21 2. Diagnosis of: * early-stage breast cancer at low risk of recurrence * defined as clinical stage 1 or 2 * completed primary treatment (surgery, chemotherapy \[adjuvant, patients may continue to be treated with neoadjuvant\], and/or radiation) \> 6 months ago * oncologist reported risk of recurrence at 10 years \< 20% * late-stage ovarian cancer at high risk of recurrence * defined as Clinical stage 3 or 4 * currently in remission * oncologist reported risk of recurrence at 10 years \> 80% 2. Functional Status defined as: * Eastern Cooperative Oncology Group (ECOG) ≤1 * Palliative Performance Scale (PPS) ≥60% * Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. Have an identified support person * Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing 6. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study. Exclusion Criteria: 1. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: * Congestive heart failure * Valvular heart disease * Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e., QTC interval \> 450) * Recent acute myocardial infarction or evidence of ischemia * Malignant hypertension * Congenital long QT syndrome * Acute renal failure * Severe hepatic impairment * Respiratory failure * eGFR \< 50 mL/min/1.73m2 * LFTs \> 1.5 x ULN * WBC \< 5 x 10\*9/L * Hemoglobin \< 8.0 g/dL * Platelets \< 150 x 10\*9/L 2. Risk for hypertensive crisis defined as: Screening and Baseline blood pressure \>140/90 mmHg 3. Significant central nervous system (CNS) pathology Examples include: * Primary or secondary cerebral neoplasm * Epilepsy * History of stroke * Cerebral aneurysm * Dementia * Delirium 4. Primary psychotic or affective psychotic disorders Examples include current or past DSM-5 criteria for: * Schizophrenia spectrum disorders * Schizoaffective disorder * Bipolar I or bipolar II disorder * Major Depressive Disorder with psychotic features * Prior history of psychosis due to medical condition or substance use 5. Family history of psychotic or serious bipolar spectrum illnesses. Examples include first-degree relative with: * Schizophrenia spectrum disorders * Schizoaffective disorder * Bipolar I disorder with psychotic features 6. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation and judgement. Examples include: * Agitation * Violent behavior 7. Active substance use disorders (SUDs) defined as: * DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year * DAST-10 score of 3 or higher * Two or more "yes" responses to CAGE screening questionnaire 8. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: * Any use in the last 12 months * \>25 lifetime uses 9. Clinically significant suicidality or high risk of completed suicide defined as: * 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline * Any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts * Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior 10. History of hallucinogen persisting perception disorder (HPPD) 11. Pregnancy/lactation 12. Cognitive impairment as defined by: • Montreal Cognitive Assessment Test (MoCA) \< 23 13. Concurrent Medications * Antidepressants * Centrally-acting serotonergic agents (e.g., MAO inhibitors) * Serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort) * Antipsychotics (e.g., first and second generation) * Mood stabilizers (e.g., lithium, valproic acid) * Aldehyde dehydrogenase inhibitors (e.g., disulfiram) * Significant inhibitors of UGT 1A0 or UGT 1A10 * Efavirenz 14. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone) unless prescribed, and Phencyclidine (PCP). 15. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin 16. Have any psychological or physical symptom, medication, or other relevant finding , based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study. 17. Have an allergy or intolerance to any of the materials contained in the drug product 18. Non-English speaking individual 19. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)

START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer

NCT05492682
Recruiting
Conditions Melanoma (Skin), Triple-Negative Breast ...
Phase PHASE1
Enrollment 15
Locations 7 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.

Design

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

Interventions / Regimen

  • Drug: PeptiCRAd-1 — All patients will receive PeptiCRAd-1.
  • Drug: Cyclophosphamide — All patients will be pre-treated with one single dose of Cyclophosphamide.
  • Drug: Pembrolizumab — All patients will receive 6 doses of Pembrolizumab within the study.

Primary Outcomes

  • Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 monotherapy. (From study protocol day 1 (baseline) until 1 month)
  • Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 and CPI combination. (From first month through study completion, an average of 4.5 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: 2023-02-02
Completion: 2027-05-31
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 15 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Valo Therapeutics Oy
Contact Information
Study Contact:
Kuryk, PhD
0505876088
info@valotx.com
Vanesa Gregorc
vanesa.gregorc@ircc.it
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
Matteo Simonelli
matteo.simonelli@hunimed.eu
IRCCS Istituto Clinico Humanitas
Interventions
  • Drug: PeptiCRAd-1 — All patients will receive PeptiCRAd-1.
  • Drug: Cyclophosphamide — All patients will be pre-treated with one single dose of Cyclophosphamide.
  • Drug: Pembrolizumab — All patients will receive 6 doses of Pembrolizumab within the study.
Study Locations (7 sites)
Krankenhaus Nordwest, Frankfurt, Germany
National Center for Tumor Diseases, Heidelberg, Germany
Universitätsklinikum Tübingen, Tübingen, Germany
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS, Candiolo, Italy
IRCCS Istituto Clinico Humanitas, Milan, Italy
IRCCS Ospedale San Raffaele, Milan, Italy
Università di Napoli Federico II, Naples, Italy
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent. 2. Male or female, ≥18 years of age. 3. Patients with any 1 of the following histologically confirmed tumors and who qualifies for new or continued CPI therapy and relapsing to/after standard therapy or the patient has refused or does not tolerate standard therapy: * Inoperable/metastatic cutaneous malignant melanoma * Relapsed or newly diagnosed locally advanced inoperable/metastatic TNBC * Inoperable advanced/metastatic non-squamous NSCLC * Inoperable and/or advanced Synovial or myxoid round cell sarcoma * Inoperable and/or advanced osteosarcoma * Inoperable and/or advanced colorectal cancer, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline * Inoperable and/or advanced/metastatic sarcoma, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 5. Tumor lesion which is deemed feasible for biopsy and injection 6. ECOG/WHO performance status 0 to 1. 7. Acceptable liver and renal function, defined as: * Total bilirubin ≤1.5 x upper limit of normal (ULN; does not include patients with Gilbert's Disease), and * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN, and * Serum creatinine ≤1.5 x ULN 8. Acceptable hematological function, defined as: * Hemoglobin ≥9 g/dL, and * Neutrophils ≥1.5 x 109/L, and * Platelet count ≥100 x 109/L Patients may be transfused to meet the hemoglobin entry criteria. 9. Acceptable coagulation status defined by international normalized ratio (INR) of blood clotting, prothrombin time and activated partial thromboplastin time within ≤1.5 x upper limit of normal. 10. Negative pregnancy test at screening in all women of childbearing potential (WOCBP). Such patients must agree to use a highly effective method of contraception (Appendix 1) during study intervention and for 3 months after the last virus treatment, 4 months after the last dose of pembrolizumab, and 12 months after CPO dosing. Male patients and male partners of female patients must also use barrier contraception, i.e., condom, for the time periods specified for WOCBP, plus a further 3 month period. Urine pregnancy tests should have a sensitivity of at least 25 mIU/mL for human chorionic gonadotropin (hCG). If the urine test is positive, it must be followed by a quantitative analysis of hCG concentration in blood. 11. Prior therapy with an immune CPI is allowed provided a 6-week washout period is observed for patients with prior programmed cell death (PD)1 or PDL1 treatment Exclusion Criteria: 1. Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1. 2. Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of \>10 mg/day prednisone) within 4 weeks before Day 1. Inhaled or topical corticosteroid use is allowed. 3. Prior or concomitant radiotherapy within 4 weeks before Day 1. 4. Participation in a study with an investigational drug or device within 4 weeks prior to Day 1. 5. Active bacterial, viral, or fungal infection that requires systemic therapy. 6. Active autoimmune disease that has required systemic treatment in the past two years. 7. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study. 8. Any concomitant medical condition requiring receipt of a therapeutic anticoagulant that, in the opinion of the treating physician, cannot safely be withheld to allow for repeated injection of PeptiCRAd 1 and tumor biopsies. 9. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C or active tuberculosis. 10. Known active central nervous system metastases. Patients with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage are excluded. Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted. 11. Any prior severe AE according to Common Terminology Criteria for Adverse Events (CTCAE), severe hypersensitivity reaction attributed to prior anti-PD1 or PDL1 therapy or components of the study intervention or has a history of any contraindication that, in the investigator's opinion, would contraindicate pembrolizumab administration such as: * Resolution of side effect of prior anti-PD1 or PDL1 therapy to Grade 1 * Grade 2 or higher pneumonitis * Grade 4 AST or ALT elevation * Grade 3 or higher colitis attributable to immunotherapy Note: in the absence of clinical symptoms of pancreatitis, elevations of amylase or lipase are not contraindications to therapy on this trial. 12. History of or planned tissue / organ transplant. 13. Females who are pregnant or breast feeding or expecting to conceive within the projected duration of the study starting with the screening visit or males expecting to father children within the projected duration of the study starting with the screening visit. 14. Unwillingness or inability to comply with the study protocol for any reason. 15. Admission to an institution by virtue of an order issued by the judicial or administrative authorities. 16. Sponsor or Contract Research Organization employees, or employees under the direct supervision of the investigator or the investigational sites and/or involved directly in the study. 17. Prior or concurrent malignancy, unless the natural history or treatment of the disease does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.

Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors

NCT07410494
Recruiting
Conditions Cancer, Breast Cancer, Non-Small Cell Lu...
Phase PHASE1, PHASE2
Enrollment 85
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.

Design

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

Interventions / Regimen

  • Biological: EB-SELECT Single-Target CAR-NK Cells — Donor-derived CAR-NK cells expressing a single CAR selected from the target menu. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion. Similar conditioning drugs are used in CAR-NK solid tumor trials.
  • Biological: Dual-Target Antigen-Selected CAR-NK — Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion . Similar conditioning drugs are used in CAR-NK solid tumor trials.

Primary Outcomes

  • Incidence, type, and severity of adverse events (AEs), graded by CTCAE v5.0 (28 DAYS)
  • Incidence of Dose-Limiting Toxicities (DLTs) (28 DAYS)
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: 2026-02-01
Completion: 2028-12-28
Eligibility
Age: 8 Years – 85 Years
Sex: ALL
Volunteers: false
Enrollment: 85 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Essen Biotech
Contact Information
Study Contact:
Rhoda M Smith, PHD
+12077706670
clinical-trials@essen-biotech.com
SAMI XI, MD
+14012275001
SFM@districtonehospital.com
District One Hospital
Interventions
  • Biological: EB-SELECT Single-Target CAR-NK Cells — Donor-derived CAR-NK cells expressing a single CAR selected from the target menu. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion. Similar conditioning drugs are used in CAR-NK solid tumor trials.
  • Biological: Dual-Target Antigen-Selected CAR-NK — Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion . Similar conditioning drugs are used in CAR-NK solid tumor trials.
Study Locations (1 sites)
District One Hospital, Beijing, Beijing Municipality 086-373 China
Eligibility Criteria
Inclusion Criteria: * Age 18-75 years. * Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available. * Targetable antigen positivity from the protocol target menu based on: tissue biopsy and/or liquid biopsy platform (as defined in the lab manual). * Arm assignment rules : * Arm A: ≥1 antigen meets "positive" threshold * Arm B: ≥2 antigens meet "positive" threshold * ECOG performance status 0-1 (or 0-2 ). * At least one measurable lesion by RECIST 1.1. * Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits. * Willingness to undergo blood draws and required biopsies (when medically feasible). * Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment. Exclusion Criteria: * Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period . * Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV/HCV with detectable viral load (per local policy). * Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ). * Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold. * Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk. * Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout). * Pregnant or breastfeeding.

Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

NCT07340541
Recruiting
Conditions Breast Cancer, Metastatic Breast Cancer,...
Phase PHASE2
Enrollment 700
Locations 6 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive/hormone receptor-negative (ER+/HR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.

Design

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

Interventions / Regimen

  • Drug: SERD* + abemaciclib — Investigators choice Selective Estrogen Receptor Degrader + abemaciclib therapy.
  • Drug: SERD* + everolimus — Investigators choice Selective Estrogen Receptor Degrader + everolimus therapy.
  • Drug: SERD* + everolimus or capecitabine — Investigators choice Selective Estrogen Receptor Degrader + everolimus or capecitabine therapy.
  • Drug: SOC — standard-of-care (SOC) chemotherapy in breast cancer
  • Drug: Antiandrogen — Antiandrogen therapy

Primary Outcomes

  • Intra-Individual 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: 2026-02-16
Completion: 2031-06-02
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 700 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
Collaborators: Advanced Research Projects Agency for Health (ARPA-H), Breast Cancer Research Foundation, Translational Breast Cancer Research Consortium
Principal Investigators:
  • Lisa A Carey, MD (PRINCIPAL_INVESTIGATOR) - UNC Lineberger Comprehensive Cancer Center
  • Eric Winer, MD (STUDY_CHAIR) - Yale University
Contact Information
Study Contact:
Emily L Schworer
919-984-0000
emily_lane@med.unc.edu
Ana Gallegos
ana_gallegos@med.unc.edu
Sarah Mooney
sarah.mooney@yale.edu
Yale Cancer Center Clinical Trials Office
Interventions
  • Drug: SERD* + abemaciclib — Investigators choice Selective Estrogen Receptor Degrader + abemaciclib therapy.
  • Drug: SERD* + everolimus — Investigators choice Selective Estrogen Receptor Degrader + everolimus therapy.
  • Drug: SERD* + everolimus or capecitabine — Investigators choice Selective Estrogen Receptor Degrader + everolimus or capecitabine therapy.
  • Drug: SOC — standard-of-care (SOC) chemotherapy in breast cancer
  • Drug: Antiandrogen — Antiandrogen therapy
Study Locations (6 sites)
Yale Cancer Center Clinical Trials Office, New Haven, Connecticut 06519 United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland 21287 United States
Mayo Clinic, Rochester, Minnesota 55905 United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7305 United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania 19104 United States
Baylor College of Medicine, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subject is willing and able to comply with study procedures based on the judgement of the investigator. * Age ≥ 18 years of age at the time of consent * ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale). * Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol Exclusion Criteria: * Inaccessible metastatic lesion to research biopsy * Subject has already initiated 2nd line therapy * Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation

Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

NCT06409390
Recruiting
Conditions Metastatic Breast Cancer
Phase PHASE2
Enrollment 15
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of the study is to test a treatment strategy with currently approved drugs to see if it is practical to administer the available drugs in a new way that researchers hope could be more effective in treating metastatic breast cancer.

Design

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

Interventions / Regimen

  • Drug: Taxotere — 75 mg/m2 once every 21 days for 4 cycles
  • Drug: Cytoxan — 600 mg/m2 once every 21 days for 4 cycles
  • Drug: Trastuzumab deruxtecan — 5.4 mg/kg once every 21 days for 5 cycles
  • Drug: Sacituzumab govitecan — 10 mg/kg on days 1 and 8 cycled every 21 days for 5 cycles
  • Drug: Xeloda — 1000 mg/m2 orally twice daily for 14 days cycled every 21 days for 5 cycles
  • Drug: Fulvestrant — 500 mg intramuscular (IM) on days 1, 15 and 28 of the first cycle followed by every 28 days for a total of 4 cycles
  • Drug: Ribociclib — 600 mg orally daily 21 days on, 7 days off
  • Drug: Abemaciclib — 150 mg by mouth twice daily

Primary Outcomes

  • Feasibility of Sequential Therapy (Up to 18 months)
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Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-08-14
Completion: 2027-04
Eligibility
Age: 18 Years and older
Sex: FEMALE
Volunteers: false
Enrollment: 15 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Principal Investigators:
  • Aixa Soyano, MD (PRINCIPAL_INVESTIGATOR) - Moffitt Cancer Center
Contact Information
Study Contact:
Luza Herrera Dominguez
813-745-5332
Luza.Herrera@moffitt.org
Aixa Soyano, MD
Moffitt Cancer Center
Dana Ataya, MD
Moffitt Cancer Center
Interventions
  • Drug: Taxotere — 75 mg/m2 once every 21 days for 4 cycles
  • Drug: Cytoxan — 600 mg/m2 once every 21 days for 4 cycles
  • Drug: Trastuzumab deruxtecan — 5.4 mg/kg once every 21 days for 5 cycles
  • Drug: Sacituzumab govitecan — 10 mg/kg on days 1 and 8 cycled every 21 days for 5 cycles
  • Drug: Xeloda — 1000 mg/m2 orally twice daily for 14 days cycled every 21 days for 5 cycles
Study Locations (1 sites)
Moffitt Cancer Center, Tampa, Florida 33612 United States
Eligibility Criteria
Inclusion Criteria: * Female patients 18 years or older * Histologically or cytologically confirmed diagnosis of hormone positive HER2 negative metastatic breast cancer per ASCO/CAP criteria (Allison et al, 2020, Wolff et al, 2018), with diagnosis established through either a breast/axillary biopsy or biopsy of a metastatic lesion. * Hormone positive MBC previously treated with endocrine therapy with either an aromatase inhibitor or Tamoxifen (alone or in combination with a CDK4/6 inhibitor). * Elevated breast tumor markers which may include cancer antigen 15-3 (CA 15-3) levels above the institutional upper limit of normal (ULN) range of 0.0-31.0 U/mL, cancer antigen 27-29 (CA 27-29) (range \<38 U/mL) and/or elevated Carcinoembryonic antigen (CEA) above institutional upper limit of normal (range 0.0 - 5.2 ng/mL). * Presence of measurable disease on imaging via RECIST v1.1. * ECOG performance status 0-1. * Participants must have adequate organ and marrow function as defined in the protocol. * A negative pregnancy test for pre-menopausal women of childbearing potential. * Pre-menopausal women of childbearing potential who are sexually active with a male partner must agree to use adequate contraception prior to the study, for the duration of study participation. * Inclusion of minorities: patients of all races and ethnic groups who meet the above inclusion and below exclusion criteria are eligible for this trial. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the participant's behalf. Exclusion Criteria: * Have previously received Fulvestrant for treatment of their breast cancer. * History of allergic reactions attributed to the study drugs. * Documented brain metastasis or active or newly diagnosed CNS metastases, including meningeal carcinomatosis, because systemic treatment would need to be paused for these patients. * Treatment with any investigational compound within 30 days prior to the first dose of study drugs or during this study. * Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. * Uncontrolled intercurrent illness including-but not limited to-ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis. * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. * Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen \[HBsAg\]), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Participants with positive HCV antibody are eligible if polymerase chain reaction is negative for HCV RNA. * Concurrent or prior use of immunosuppressive medication within 14 days before the first dose of study drugs, with the following exceptions: premedication with dexamethasone, intranasal, inhaled, topical or local steroid injections, systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reactions (e.g., premedication for iodinated contrast allergy before CT scan). * Inability to comply with protocol requirements. * Pregnant and/or breastfeeding women are excluded.