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

Recruiting now · Phase 1

Conditions studied: Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT06756932

Run by

BeOne Medicines

People needed

120

Starts

2025-02-04

Expected to finish

2027-07-30

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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