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NCT07222267PHASE1Recruiting

An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors

BeOne Medicines

Start Date

12/11/2025

Completion Date

1/13/2037

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A/B inhibitor) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Part 1A: Participants with histologically or cytologically confirmed advanced, metastatic breast cancer and other solid tumors who have exhausted, are intolerant of all available standard of care therapies, and/or without available standard of care therapies. * Part 1B and Part 2A: Participants with advanced breast cancer with 1 to 3 prior lines of systemic therapy in the metastatic setting. Prior lines in the advanced/ metastatic setting may not exceed 2 lines of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload). * Parts 2B and 2C: Participants with advanced breast cancer enrolled in regions where cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are not approved and/or not available as the first-line treatment and who are CDK4/6 inhibitor treatment naïve and did not receive any previous systemic treatment for advanced disease. * Participants with breast cancer must have histologically or cytologically confirmed advanced breast cancer at the time of most recent testing, based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. * Female participants with metastatic breast cancer must be postmenopausal or receiving ovarian function suppression treatment. * Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate organ function. Exclusion Criteria: * Prior exposure to KAT6A/B or KAT7 inhibitors/degraders. * Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis. * Participants with any malignancy ≤ 3 years before screening for the study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively which in the opinion of the investigator is unlikely to require intervention during the study. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

BG-75202

DRUG

CDK4 Inhibitor

DRUG

Estrogen Receptor Antagonist

DRUG

Aromatase Inhibitor

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Conditions

Breast CancerAdvanced Solid Tumor

Locations

University of Alabama At Birmingham Hospital

Birmingham, Alabama 35294-0004

United States

Yale Cancer Center

New Haven, Connecticut 06510

United States

Washington University in St Louis

St Louis, Missouri 63110-1010

United States

Next Oncology Austin

Austin, Texas 78758

United States

The University of Texas Md Anderson Cancer Center

Houston, Texas 77030-4009

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109-4433

United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

Chris Obrien Lifehouse

Camperdown, New South Wales NSW 2050

Australia

Cancer Research South Australia

Adelaide, South Australia SA 5000

Australia

Austin Health

Heidelberg, Victoria VIC 3084

Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria VIC 3000

Australia

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality 100021

China

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian 361003

China

Sun Yat Sen University Cancer Center Huangpu Branch

Guangzhou, Guangdong 510555

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

Jiangsu Province Hospital Longjiang Branch

Nanjing, Jiangsu 210036

China

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality 201321

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang 310016

China

Istituto Europeo Di Oncologia

Milan, 20141

Italy

Istituto Nazionale Tumori Fondazione G Pascale

Naples, 80131

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Hospital Universitario Vall Dhebron

Barcelona, 08035

Spain

Next Oncology Barcelona

Barcelona, 8023

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Clinico San Carlos

Madrid, 28240

Spain

Hospital Universitario Virgen de La Victoria

Málaga, 29010

Spain