A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
BeOne Medicines
Study ID
NCT07226349
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • BG-75098 — DRUG
    Administered orally.
  • BGB-43395 — DRUG
    Administered orally.
  • Fulvestrant — DRUG
    Administered by intramuscular injection.

Study Details

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.

Key Dates

Start date
Dec 11, 2025
Status verified
Jun 2026
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

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

Arms

  • Experimental: Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy
    Sequential cohorts of increasing dose levels of BG-75098 will be evaluated as monotherapy.
  • Experimental: Phase 1a, Part B: Dose Escalation, BG-75098 Combination
    Sequential cohorts of increasing dose levels of BG-75098 will be evaluated in combination with BGB-43395 and fulvestrant.
  • Experimental: Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination
    Participants will receive BG-75098 at the recommended dose level from Phase 1a in combination with BGB-43395 and fulvestrant.
  • Experimental: Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy
    Participants will receive BG-75098 as monotherapy at the recommended dose level from Phase 1a.

Primary Outcome Measure

Phase 1a: Number of Participants with Adverse Events (AEs) [ Time Frame: From first dose to 30 days after last dose, up to approximately 12 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Alabama At Birmingham HospitalBirminghamAlabama35294-0004-
Yale Cancer CenterNew HavenConnecticut06510-
Sidney Kimmel Comprehensive Cancer At Johns HopkinsBaltimoreMaryland21287-
Next HoustonHoustonTexas77054-
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-4009-
Medical College of WisconsinMilwaukeeWisconsin53226-1222-

Find similar trials in Birmingham, AL

By research site
University of Alabama At Birmingham Hospital· Birmingham, ALYale Cancer Center· New Haven, CTSidney Kimmel Comprehensive Cancer At Johns Hopkins· Baltimore, MDNext Houston· Houston, TXThe University of Texas Md Anderson Cancer Center· Houston, TXMedical College of Wisconsin· Milwaukee, WI

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