A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
BeOne Medicines
Study ID
NCT06625593
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-C137 — DRUG
    Administered intravenously
  • Anticancer Agents — DRUG
    Administered intravenously or orally

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation and Safety Expansion) and Phase 1b (Dose Expansion).

Key Dates

Start date
Dec 9, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Phase 1a: Monotherapy Dose Escalation and Safety Expansion
    Sequential cohorts of increasing dose levels of BG-C137 will be evaluated as monotherapy
  • Experimental: Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion
    Sequential cohorts will be evaluated to confirm the safety levels of BG-C137 in combination with other anticancer agents at selected dose levels that have been determined to be safe in Monotherapy Dose Escalation
  • Experimental: Phase 1b: Dose Expansion
    Recommended Dose(s) of BG-C137 as determined from Ph1a will be evaluated in select indications

Primary Outcome Measure

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Usc Norris Comprehensive Cancer Center (Nccc)Los AngelesCalifornia90089-1019-
Yale Cancer CenterNew HavenConnecticut06510-
Mayo Clinic RochesterRochesterMinnesota55905-0001-
Md Anderson Cancer CenterHoustonTexas77030-3907-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-4433-
University of WisconsinMadisonWisconsin53792-0001-

Find similar trials in Los Angeles, CA

By research site
Usc Norris Comprehensive Cancer Center (Nccc)· Los Angeles, CAYale Cancer Center· New Haven, CTMayo Clinic Rochester· Rochester, MNMd Anderson Cancer Center· Houston, TXFred Hutchinson Cancer Research Center· Seattle, WAUniversity of Wisconsin· Madison, WI

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