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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
BeOne Medicines
Study ID
NCT07222267
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BG-75202 — DRUG
    Administered orally.
  • CDK4 Inhibitor — DRUG
    Administered orally.
  • Estrogen Receptor Antagonist — DRUG
    Administered by intramuscular injection.
  • Aromatase Inhibitor — DRUG
    Administered orally.

Study Details

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.

Key Dates

Start date
Dec 11, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2029
Completion
Jan 13, 2037

Study Design

Enrollment
86 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy
    Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
  • Experimental: Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist
    Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist.
  • Experimental: Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist
    Participants will receive BG-75202 in combination with an estrogen receptor antagonist.
  • Experimental: Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor
    Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor.
  • Experimental: Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor
    Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor.

Primary Outcome Measure

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

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Alabama At Birmingham HospitalBirminghamAlabama35294-0004-
Yale Cancer CenterNew HavenConnecticut06510-
Washington University in St LouisSt LouisMissouri63110-1010-
Next Oncology AustinAustinTexas78758-
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-4009-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-4433-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Alabama At Birmingham Hospital· Birmingham, ALYale Cancer Center· New Haven, CTWashington University in St Louis· St Louis, MONext Oncology Austin· Austin, TXThe University of Texas Md Anderson Cancer Center· Houston, TXFred Hutchinson Cancer Research Center· Seattle, WA

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