Investigating BG-75202 for Advanced Solid Tumors

This study is looking at a new drug called BG-75202, both by itself and with other cancer medicines like CDK4 Inhibitors, Estrogen Receptor Antagonists, and Aromatase Inhibitors. It aims to see how safe these treatments are, how well your body handles them, and if they can help shrink tumors. You might be able to join if you have advanced breast cancer or other advanced solid tumors that have not responded to standard treatments or if you cannot tolerate them. Researchers will be looking at side effects and how many participants respond to the treatment. The study plans to enroll about 86 people, but its current recruitment status is unclear.

Study design
This study is an interventional study, meaning participants will receive specific treatments. It plans to enroll about 86 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects from the first dose up to 30 days after the last dose or starting a new cancer treatment, for approximately 12 months. Overall response to treatment will be measured for up to approximately 2 years.

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NCT07222267

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
BeOne Medicines
~86 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:BG-75202CDK4 InhibitorEstrogen Receptor AntagonistAromatase Inhibitor

At a glance

Recruiting sites
30 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of Participants with Adverse Events (AEs)
Measured over From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months
+2 more outcomes measured
Breast Cancer
Advanced Solid Tumor
31 sites across 20 states
Spain5
Italy4
Texas2
New South Wales2
Victoria2
Beijing Municipality2
Alabama1
Connecticut1
  • Study Director · STUDY_DIRECTOR · BeOne Medicines

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Eligibility criteria

Inclusion

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

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.
  • Part 1: Number of Participants with Adverse Events (AEs)From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria.

  • Part 1: Recommended Dose for Expansion (RDFE)Estimated approximately 1 year

    The RDFE is based on the maximum tolerated dose (MTD) or maximum administered dose (MAD) with consideration of the tolerability, pharmacokinetics (PK), pharmacodynamics, antitumor activity, and any other available relevant data.

  • Part 2: Overall Response Rate (ORR)Up to approximately 2 years

    ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).