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

Last updated: June 1, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Recruiting

Phase

1

Condition

Cancer

Breast Cancer

Treatment

BG-75202

Aromatase Inhibitor

CDK4 Inhibitor

Clinical Study ID

NCT07222267
BG-75202-101
2025-523553-34-00
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Part 1A: Participants with histologically or cytologically confirmed advanced,metastatic breast cancer and other solid tumors who have exhausted, are intolerantof all available standard of care therapies, and/or without available standard ofcare therapies.

  • Part 1B and Part 2A: Participants with advanced breast cancer with 1 to 3 priorlines of systemic therapy in the metastatic setting. Prior lines in the advanced/metastatic setting may not exceed 2 lines of chemotherapy (inclusive ofantibody-drug conjugate with cytotoxic payload).

  • Parts 2B and 2C: Participants with advanced breast cancer enrolled in regions wherecyclin-dependent kinase 4/6 (CDK4/6) inhibitors are not approved and/or notavailable as the first-line treatment and who are CDK4/6 inhibitor treatment naïveand did not receive any previous systemic treatment for advanced disease.

  • Participants with breast cancer must have histologically or cytologically confirmedadvanced breast cancer at the time of most recent testing, based on American Societyof Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.

  • Female participants with metastatic breast cancer must be postmenopausal orreceiving 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

Exclusion Criteria:

  • Prior exposure to KAT6A/B or KAT7 inhibitors/degraders.

  • Patients with active leptomeningeal disease or uncontrolled, untreated brainmetastasis.

  • Participants with any malignancy ≤ 3 years before screening for the study except forthe specific cancer under investigation in this study and any locally recurringcancer that has been treated curatively which in the opinion of the investigator isunlikely to require intervention during the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 86
Treatment Group(s): 4
Primary Treatment: BG-75202
Phase: 1
Study Start date:
December 11, 2025
Estimated Completion Date:
January 13, 2037

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales NSW 2148
    Australia

    Active - Recruiting

  • Chris Obrien Lifehouse

    Camperdown, New South Wales NSW 2050
    Australia

    Active - Recruiting

  • Cancer Research South Australia

    Adelaide, South Australia SA 5000
    Australia

    Active - Recruiting

  • Austin Health

    Heidelberg, Victoria VIC 3084
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria VIC 3000
    Australia

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality 100142
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality 100021
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Center Huangpu Branch

    Guangzhou, Guangdong 510555
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Centerhuangpu Branch

    Guangzhou, Guangdong 510555
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

  • Jiangsu Province Hospital Longjiang Branch

    Nanjing, Jiangsu 210036
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Centerpudong

    Shanghai, Shanghai Municipality 201321
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality 300060
    China

    Active - Recruiting

  • Istituto Europeo Di Oncologia

    Milan, 20141
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Fondazione G Pascale

    Naples, 80131
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Next Oncology Barcelona

    Barcelona, 8023
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28240
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama 35294-0004
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Washington University in St Louis

    St Louis, Missouri 63110-1010
    United States

    Active - Recruiting

  • Next Oncology Austin

    Austin, Texas 78758
    United States

    Active - Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109-4433
    United States

    Active - Recruiting

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