BG-75202 alone and with other therapies for adults with advanced breast cancer and other solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label trial gives BG-75202 alone and in combination with CDK4 inhibitors, estrogen receptor antagonists, or aromatase inhibitors to adults with advanced breast cancer or other solid tumors to measure safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. The study is organized into dose-escalation and cohort-expansion parts (Parts 1A, 1B, 2A–2C) to find appropriate dosing and explore combination regimens. Eligibility rules vary by cohort, including patients who have exhausted standard therapies as well as cohorts limited to defined prior-line windows or CDK4/6 inhibitor–naïve participants depending on regional availability. The sponsor, BeOne Medicines, is running the trial at academic centers including University of Alabama at Birmingham, Yale Cancer Center, and Washington University in St. Louis.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama At Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Washington University in St Louis
  St Louis, Missouri, United States Recruiting
• Next Oncology Austin
  Austin, Texas, United States Recruiting
• The University of Texas Md Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Fred Hutchinson Cancer Research Center
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 877-828-5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.