Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
BeOne Medicines
Study ID
NCT06598800
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

  • Drug: BG-T187 — DRUG
    administered subcutaneously
  • Other Therapeutic Agents — DRUG
    administered intravenously

Study Details

This is a first-in-human (FIH), Phase 1a/1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced solid tumors.

Key Dates

Start date
Oct 18, 2024
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

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

Arms

  • Experimental: Phase 1a: Part A: Monotherapy Dose Escalation with Intravenous Administration
    Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.
  • Experimental: Phase 1a: Part B: Monotherapy Dose Escalation with Subcutaneous Administration
    Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.
  • Experimental: Phase 1a Part C: Safety Expansion
    BG-T187 dose levels that have been determined to be safe and tolerable in Part B will be investigated.
  • Experimental: Phase 1b: Monotherapy Dose Expansion with Subcutaneous Administration
    Participants will receive BG-T187 monotherapy at the recommended dose(s) for expansion (RDFE) determined in Phase 1a.
  • Experimental: Phase 1b: Combination Therapy: BG-T187 + Other Therapeutic Agents
    Participants will receive BG-T187 in combination with Other Therapeutic Agents.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Hackensack University Medical CenterHackensackNew Jersey07601-1915-
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-4009-
Next VirginiaFairfaxVirginia22031-
Washington University, St Louis, Division of OncologyMadisonWisconsin53708-8056-

Find similar trials in Hackensack, NJ

By research site
Hackensack University Medical Center· Hackensack, NJThe University of Texas Md Anderson Cancer Center· Houston, TXNext Virginia· Fairfax, VAWashington University, St Louis, Division of Oncology· Madison, WI

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