Recruiting
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.
ClinicalTrials.gov IDNCT06120283
PhasePHASE1
Enrollment433
SponsorBeOne Medicines
Age18 Years
SexALL
Conditions studied
Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Hormone Receptor Positive Malignant Neoplasm of Breast, HER2-negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
About this study
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.
Interventions
- Drug: BGB-43395 — Planned doses administered orally.
- Drug: Fulvestrant — Standard dose administered via intramuscular injection.
- Drug: Letrozole — Standard dose administered orally as a tablet.
- Drug: Elacestrant — Standard dose administered orally as a tablet.
- Drug: Anti-Diarrheal Agent — Administered orally as a tablet.
Primary outcomes
- Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Up to approximately 60 months)
- Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395 (Up to approximately 60 months)
- Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395 (Up to approximately 60 months)
- Phase 1b: Objective Response Rate (ORR) (Up to approximately 60 months)
Eligibility information
Inclusion Criteria:
* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced/metastatic disease including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting.
* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4/6 inhibitor. For combination with letrozole, participants must be CDK4/6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.
* Phase 1b: Participants with HR+/HER2- breast cancer.
* Phase 1b: For combination with fulvestrant, participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced/metastatic disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. For combination cohorts with letrozole, participants must be CDK4/6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.
* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
* Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
* Adequate organ function without symptomatic visceral disease.
Exclusion Criteria:
* Known leptomeningeal disease or uncontrolled, untreated brain metastases.
* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
* Uncontrolled diabetes.
* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.
* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at screening.
* Participants with active hepatitis C infection.
* Prior allogeneic stem cell transplantation, or organ transplantation.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study locations
- Sarah Cannon Research Institute (Scri) At Health One, Denver, Colorado 80218-1238 United States
- Florida Cancer Specialists and Research Institute, Lake Mary, Florida 32746-2115 United States
- Karmanos Cancer Institute, Detroit, Michigan 48201-2013 United States
- Washington University School of Medicine, St Louis, Missouri 63110-1010 United States
- Duke Cancer Center, Durham, North Carolina 27710-2000 United States
- James Cancer Hospital and Solove Research Institute, Columbus, Ohio 43210-1240 United States
- Scri Oncology Partners, Nashville, Tennessee 37203-1503 United States
- The University of Texas Md Anderson Cancer Center, Houston, Texas 77030-4009 United States
- Next Oncology Dallas, Irving, Texas 75039-2743 United States
- Next Oncology, San Antonio, Texas 78229-6028 United States
Showing 10 of 62 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.