RecruitingPhase 1NCT06756932

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

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+/HER2- Metastatic Breast Cancer

Sponsor

BeOne Medicines

Enrollment

120 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer HER2-negative Breast Cancer Hormone Receptor-Positive Breast Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BGB-21447 (a Bcl-2 inhibitor, which blocks a protein that helps cancer cells survive) in combination with other hormone-blocking medicines for adults with a type of breast cancer called HR-positive, HER2-negative breast cancer that has spread to other parts of the body. **You may be eligible if...** - You have confirmed HR+/HER2- metastatic breast cancer - You have received at least one prior treatment including a hormone therapy and a CDK4/6 inhibitor - You are in generally good health (able to carry out daily activities) - Premenopausal women must be willing to use ovarian suppression therapy **You may NOT be eligible if...** - You have previously been treated with a Bcl-2 inhibitor - You have brain metastases that are uncontrolled or untreated - You have had another cancer within the past 3 years - You have active or past hepatitis B or C infection - You have uncontrolled diabetes (for certain treatment groups) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-21447

Administered orally.

DRUGFulvestrant

Administered via intramuscular injection.

DRUGBGB-43395

Administered orally.

Locations(16)

Hoag Memorial Presbyterian

Newport Beach, California, United States

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

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06756932

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