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.
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
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
- 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
- Blacktown Cancer and Haematology Centre, Blacktown, New South Wales NSW 2148 Australia
Showing 10 of 61 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-06.