BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
BGB-21447: Administered orally.
Fulvestrant: Administered via intramuscular injection.
BGB-43395: Administered orally.
Study summary
This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+/HER2- metastatic breast cancer.
Eligibility
Primary outcome measure(s)
- Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — From the first dose of study drug(s) to 30 days after the last dose; up to approximately 6 months
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and AEs that meet protocol-defined dose-limiting toxicity criteria. - Part 1: Recommended Dose for Expansion (RDFE) of BGB-21447 in combination with fulvestrant and in combination with fulvestrant and BGB-43395 — From first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 6 to 9 months
RDFE of BGB-21447 in combination with fulvestrant and in combination with fulvestrant and BGB-43395 will be determined based upon the maximum tolerated dose (MTD) or maximum administered dose (MAD). - Part 2: Objective Response Rate (ORR) — Approximately 12 months
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | Recruiting |
| Md Anderson Cancer Center | Houston | Texas | Recruiting |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | Recruiting |
| Saint Vincents Hospital Sydney | Darlinghurst | New South Wales | Terminated |
| Calvary Mater Newcastle | Waratah | New South Wales | Recruiting |
| Sunshine Coast University Private Hospital | Birtinya | Queensland | Recruiting |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | Recruiting |
| Western Health Sunshine Hospital | St Albans | Victoria | Recruiting |
| Linear Clinical Research | Nedlands | Western Australia | Recruiting |
| Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) | Guangzhou | Guangdong | Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Recruiting |
| Fudan University Shanghai Cancer Centerpudong | Shanghai | Shanghai Municipality | Recruiting |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | Recruiting |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06756932 on ClinicalTrials.gov ↗ ← All trials in the USA