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Clinical Trials in the USA / NCT07222267
Recruiting Phase 1

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

NCT07222267 · tracked via the Priya Life Science USA tracker
Sponsor
BeOne Medicines
Phase
Phase 1
Started
2025-12-11
Last updated
2026-08-14

Condition(s) studied

Breast CancerAdvanced Solid Tumor

Investigational drug(s) / intervention(s)

BG-75202CDK4 InhibitorEstrogen Receptor AntagonistAromatase Inhibitor

BG-75202: Administered orally.

CDK4 Inhibitor: Administered orally.

Estrogen Receptor Antagonist: Administered by intramuscular injection.

Aromatase Inhibitor: Administered orally.

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
University of Alabama At Birmingham Hospital Birmingham Alabama Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
Washington University in St Louis St Louis Missouri Recruiting
Next Oncology Austin Austin Texas Recruiting
The University of Texas Md Anderson Cancer Center Houston Texas Recruiting
Fred Hutchinson Cancer Research Center Seattle Washington Recruiting
Blacktown Cancer and Haematology Centre Blacktown New South Wales Recruiting
Chris Obrien Lifehouse Camperdown New South Wales Recruiting
Cancer Research South Australia Adelaide South Australia Recruiting
Austin Health Heidelberg Victoria Recruiting
Peter Maccallum Cancer Centre Melbourne Victoria Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Chongqing University Cancer Hospital Chongqing Chongqing Municipality Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
Sun Yat Sen University Cancer Center Huangpu Branch Guangzhou Guangdong Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
Jiangsu Province Hospital Longjiang Branch Nanjing Jiangsu Recruiting
Fudan University Shanghai Cancer Centerpudong Shanghai Shanghai Municipality Recruiting
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Istituto Europeo Di Oncologia Milan Italy Recruiting
Istituto Nazionale Tumori Fondazione G Pascale Naples Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Roma Italy Recruiting
Istituto Clinico Humanitas Rozzano Italy Recruiting
Auckland City Hospital Auckland Grafton Not Yet Recruiting
Hospital Universitario Vall Dhebron Barcelona Spain Recruiting
Next Oncology Barcelona Barcelona Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Clinico San Carlos Madrid Spain Recruiting
Hospital Universitario Virgen de La Victoria Málaga Spain Recruiting

More BeOne Medicines trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07222267 on ClinicalTrials.gov ↗ ← All trials in the USA