An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
BeOne Medicines
Study ID
NCT06589596
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

  • BGB-58067 — DRUG
    Planned doses administered on specified days per protocol.
  • BG-89894 — DRUG
    Planned doses administered on specified days per protocol.
  • Standard of Care Therapy — DRUG
    Administered in accordance with relevant local guidelines and/or prescribing information.

Study Details

This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Key Dates

Start date
Jan 10, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: Phase 1a: BGB-58067 Monotherapy Dose Escalation and Safety Expansion
    Sequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated.
  • Experimental: Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation
    Sequential cohorts of increasing dose levels of BGB-58067 in combination with BG-89894 will be evaluated. Enrollment in this combination has been discontinued.
  • Experimental: Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation
    Sequential cohorts of increasing dose levels of BGB-58067 in combination with standard of care therapy will be evaluated.
  • Experimental: Phase 1b: Dose Expansion and Optimization
    Recommended Dose(s) for Expansion (RDFE\[s\]) of BGB-58067 alone and in combination with standard of care therapy will be evaluated for selected indications and regimen(s) based on emerging data.

Primary Outcome Measure

Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events [ Time Frame: From first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 13 months) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Usc Norris Comprehensive Cancer Center (Nccc)Los AngelesCalifornia90089-1019-
AdventhealthCelebrationFlorida34747-4606-
Dana Farber Cancer InstituteBostonMassachusetts02215-5418-
Washington University School of MedicineSt LouisMissouri63110-1010-
Columbia University Medical CenterNew YorkNew York10032-
Nyu Langone HealthNew YorkNew York10016-2708-
Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-4307-
Tennessee Oncology, Pllc NashvilleNashvilleTennessee37203-
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-4009-
Next DallasIrvingTexas75039-2743-
Next VirginiaFairfaxVirginia22031-

Find similar trials in Los Angeles, CA

By research site
Usc Norris Comprehensive Cancer Center (Nccc)· Los Angeles, CAAdventhealth· Celebration, FLDana Farber Cancer Institute· Boston, MAWashington University School of Medicine· St Louis, MOColumbia University Medical Center· New York, NYNyu Langone Health· New York, NY

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