A Study of BG-C477 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
BeOne Medicines
Study ID
NCT06596473
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • BG-C477 — DRUG
    Administered intravenously.
  • Tislelizumab — DRUG
    Administered intravenously.
  • Chemotherapy — DRUG
    Administered in accordance with relevant local guidelines and/or prescribing information.

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.

Key Dates

Start date
Oct 3, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Phase 1a: BG-C477 Monotherapy Dose Escalation
    Sequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy.
  • Experimental: Phase 1a: BG-C477 Monotherapy Safety Expansion
    Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in monotherapy.
  • Experimental: Phase 1b Part A: BG-C477 Monotherapy Expansion and Dose Optimization
    Participants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a.
  • Experimental: Phase 1b Part B: Combination Therapy Expansion
    Sequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with anticancer agents, including chemotherapy or tislelizumab.

Primary Outcome Measure

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of Hope Phoenix Cancer CenterGoodyearArizona85338-
City of Hope National Medical CenterDuarteCalifornia91010-3012-
University of Colorado Cancer CenterAuroraColorado80045-2517-
Yale University Yale Cancer CenterNew HavenConnecticut06520-8028-
Osf Saint Francis Medical CenterPeoriaIllinois61637-
The University of Kansas Cancer CenterWestwoodKansas66205-2003-
John Theurer Cancer Center Hackensack University Medical CenterHackensackNew Jersey07601-
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-4009-
Texas Oncology LongviewLongviewTexas75601-

Find similar trials in Goodyear, AZ

By research site
City of Hope Phoenix Cancer Center· Goodyear, AZCity of Hope National Medical Center· Duarte, CAUniversity of Colorado Cancer Center· Aurora, COYale University Yale Cancer Center· New Haven, CTOsf Saint Francis Medical Center· Peoria, ILThe University of Kansas Cancer Center· Westwood, KS

Related Studies