Home › Trials › NCT07222267

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

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors

Phase 1 Interventional BeOne Medicines · NCT07222267

This trial will test whether BG-75202, a KAT6A/B inhibitor given alone or with other cancer drugs, is safe and can help adults with advanced breast cancer or other solid tumors.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment86 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Drugs / interventionschemotherapy
Locations25 sites (Birmingham, Alabama and 24 other locations)
Trial IDNCT07222267 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed advanced or metastatic breast cancer or other solid tumors who meet cohort-specific prior-treatment rules—either having exhausted standard therapies or fitting the defined 1–3 prior-line windows or CDK4/6–naïve status for certain cohorts.

Not a fit: Patients with early-stage disease, those who still have effective standard treatments available, or those with significant organ dysfunction or contraindications to the study drugs are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, BG-75202 could provide a new treatment option that slows tumor growth alone or improves outcomes when combined with existing targeted or hormonal therapies.

How similar studies have performed: KAT6A/B inhibitors are a novel targeted class with promising preclinical results but limited clinical data, making this one of the early human trials testing BG-75202 alone and in combinations.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerAdvanced Solid TumorKAT6 inhibitor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.