Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
BeOne Medicines
Study ID
NCT06233942
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-C9074 — DRUG
    administered by intravenous infusion
  • Tislelizumab — DRUG
    administered by intravenous infusion
  • Bevacizumab — DRUG
    administered by intravenous infusion

Study Details

This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with other anticancer therapies in patients with advanced solid tumors.

Key Dates

Start date
Apr 12, 2024
Status verified
Jun 2026
Primary completion
Sep 28, 2027
Completion
May 15, 2028

Study Design

Enrollment
308 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a: Part A (Monotherapy Dose Escalation)
    BG-C9074 monotherapy dose escalation
  • Experimental: Phase 1a: Part B (Monotherapy Safety Expansion)
    BG-C9074 dose levels that have been determined to be safe and tolerable in Part A will be investigated.
  • Experimental: Phase 1a: Part C (Combination Therapy Dose Escalation)
    BG-C9074 plus tislelizumab combination at the recommended dose for expansion (RDFE).
  • Experimental: Phase 1a: Part D (Japan Cohort)
    A separate cohort in Japan will evaluate the safety of BG-C9074 monotherapy in Japanese participants with select solid tumors
  • Experimental: Phase 1b: Monotherapy Dose Expansion
    The monotherapy dose expansion phase will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 1a.
  • Experimental: Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus tislelizumab)
    This arm will assess BG-C9074 plus tislelizumab as first-line therapy in select solid tumors after completion of the dose escalation phase.
  • Experimental: Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus bevacizumab)
    This arm will assess BG-C9074 plus bevacizumab in select solid tumors participants after establishing the recommended monotherapy dose and schedule.

Primary Outcome Measure

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 3 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Usc Norris Comprehensive Cancer Center (Nccc)Los AngelesCalifornia90089-1019-
University of Colorado Cancer CenterAuroraColorado80045-2517-
Florida Cancer Specialist Research Institute Lake NonaOrlandoFlorida32827-7400-
Sidney Kimmel Comprehensive Cancer At Johns HopkinsBaltimoreMaryland21287-
James Cancer Hospital and Solove Research InstituteColumbusOhio43210-1240-

Find similar trials in Los Angeles, CA

By research site
Usc Norris Comprehensive Cancer Center (Nccc)· Los Angeles, CAUniversity of Colorado Cancer Center· Aurora, COFlorida Cancer Specialist Research Institute Lake Nona· Orlando, FLSidney Kimmel Comprehensive Cancer At Johns Hopkins· Baltimore, MDJames Cancer Hospital and Solove Research Institute· Columbus, OH

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