A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
BeOne Medicines
Study ID
NCT07181681
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Solid Tumors

Eligibility Criteria

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

Interventions

  • BG-C0902 — DRUG
    Administered by intravenous infusion

Study Details

This study is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and anti-mesenchymal-epithelial transition (MET) antibody, conjugated via an enzymatically cleavable linker to a topoisomerase 1 (TOPO1) inhibitor payload. The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C0902 in participants with advanced solid tumors. The study will be conducted in 2 phases: Phase 1a (dose escalation and safety expansion) and Phase 1b (dose expansion).

Key Dates

Start date
Nov 10, 2025
Status verified
Feb 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

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

Arms

  • Experimental: Phase 1a: Dose Escalation and Safety Expansion of BG-C0902
    Sequential cohorts of increasing dose levels of BG-C0902 will be evaluated as monotherapy.
  • Experimental: Phase 1b: Dose Expansion of BG-C0902
    The recommended dose(s) for expansion (RDFE) for BG-C0902 from Part 1 will be evaluated in selected tumors.

Primary Outcome Measure

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 24 Months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-4009-
Next OncologySan AntonioTexas78229-6028-
Next VirginiaFairfaxVirginia22031-

Find similar trials in Houston, TX

By research site
The University of Texas Md Anderson Cancer Center· Houston, TXNext Oncology· San Antonio, TXNext Virginia· Fairfax, VA

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