RECRUITING Phase 1 ClinicalTrials.gov

BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer

Sponsor: BeOne Medicines • ClinicalTrials.gov ID: NCT06756932

Registry updated: 2026-09-14

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Description

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.

Interventions

BGB-21447 (Drug)
Administered orally.
Fulvestrant (Drug)
Administered via intramuscular injection.
BGB-43395 (Drug)
Administered orally.

Eligibility criteria

Inclusion Criteria: * Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer. Part 1A and 1B: Participants must have received ≥ 1 prior line(s) of treatment for advanced/metastatic disease, including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting. Part 2: Participants must have received 1-3 prior line(s) of treatment for advanced/metastatic disease, including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting. * Female participants will be required (either continue ongoing or initiate as soon as feasible) to have ovarian function suppression using gonadotropin-releasing hormone (GnRH) agonists (such as goserelin) or be postmenopausal. * Male participants may be required to use GnRH agonists when being treated with fulvestrant at the discretion of the investigator. * Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. * Adequate organ function. * Female participants of childbearing potential and nonsterile male participants with female partners of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for 7 days after the last dose of BGB-21447, 6 months after the last dose of BGB-43395, and 2 years after the last dose of fulvestrant. * Food effect substudy only: Participants who are able and willing to fast overnight (≥ 10 hours) and consume a high-fat meal. Exclusion Criteria: * Prior Bcl-2 inhibitor exposure. For triplet combination cohorts only: Prior therapy selectively targeting CDK4. * 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, treated papillary thyroid carcinoma, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). * For Part 1B: Uncontrolled diabetes. * History of hepatitis B or active Hepatitis C infection * China Only: Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA \> 500 IU/ml (or \> 2500 copies/ml) at screening. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Conditions

Hormone-receptor-positive Breast Cancer HER2-negative Breast Cancer Metastatic Breast Cancer

Locations

University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
Md Anderson Cancer Center — Houston, Texas, United States
Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
Saint Vincents Hospital Sydney — Darlinghurst, New South Wales, Australia
Calvary Mater Newcastle — Waratah, New South Wales, Australia
Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia
Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
Western Health Sunshine Hospital — St Albans, Victoria, Australia
Linear Clinical Research — Nedlands, Western Australia, Australia
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
Fudan University Shanghai Cancer Centerpudong — Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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