A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
BeOne Medicines
Study ID
NCT05981703
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • BGB-26808 — DRUG
    Planned doses administered orally as a tablet daily.
  • Tislelizumab — DRUG
    Planned doses administered by intravenous infusion.
  • Chemotherapy — DRUG
    Administered in accordance with relevant local guidelines and/or prescribing information.

Study Details

This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.

Key Dates

Start date
Sep 21, 2023
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
217 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a: Dose Escalation
    Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.
  • Experimental: Phase 1b: Dose Expansion
    Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated.

Primary Outcome Measure

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-3012-
University of Southern California Norris ComprehensiveLos AngelesCalifornia90033-
Yale University Yale Cancer CenterNew HavenConnecticut06520-8028-
Sylvester Cancer Center, University of MiamiMiamiFlorida33136-
University of Michigan Health SystemAnn ArborMichigan48109-5316-
John Theurer Cancer Center Hackensack University Medical CenterHackensackNew Jersey07601-
Icahn School of Medicine At Mount SinaiNew YorkNew York10029-6504-
Providence Portland Medical CenterPortlandOregon97213-2933-
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-4009-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAUniversity of Southern California Norris Comprehensive· Los Angeles, CAYale University Yale Cancer Center· New Haven, CTSylvester Cancer Center, University of Miami· Miami, FLUniversity of Michigan Health System· Ann Arbor, MIJohn Theurer Cancer Center Hackensack University Medical Center· Hackensack, NJ

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