Recruiting
An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors
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.
ClinicalTrials.gov IDNCT07222267
PhasePHASE1
Enrollment86
SponsorBeOne Medicines
Age18 Years
SexALL
Conditions studied
Breast Cancer, Advanced Solid Tumor
About this study
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.
Interventions
- Drug: BG-75202 — Administered orally.
- Drug: CDK4 Inhibitor — Administered orally.
- Drug: Estrogen Receptor Antagonist — Administered by intramuscular injection.
- Drug: Aromatase Inhibitor — Administered orally.
Primary outcomes
- 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)
- Part 1: Recommended Dose for Expansion (RDFE) (Estimated approximately 1 year)
- Part 2: Overall Response Rate (ORR) (Up to approximately 2 years)
Eligibility information
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.
Study locations
- University of Alabama At Birmingham Hospital, Birmingham, Alabama 35294-0004 United States
- Yale Cancer Center, New Haven, Connecticut 06510 United States
- Washington University in St Louis, St Louis, Missouri 63110-1010 United States
- Next Oncology Austin, Austin, Texas 78758 United States
- The University of Texas Md Anderson Cancer Center, Houston, Texas 77030-4009 United States
- Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-4433 United States
- Blacktown Cancer and Haematology Centre, Blacktown, New South Wales NSW 2148 Australia
- Chris Obrien Lifehouse, Camperdown, New South Wales NSW 2050 Australia
- Cancer Research South Australia, Adelaide, South Australia SA 5000 Australia
- Austin Health, Heidelberg, Victoria VIC 3084 Australia
Showing 10 of 32 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.