A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
BeOne Medicines
Study ID
NCT06427941
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Alpha-fetoprotein (AFP)-Producing Gastric Cancer
  • Extragonadal Yolk Sac Tumors
  • Glypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer
  • Local Advanced Hepatocellular Carcinoma
  • Metastatic Hepatocellular Carcinoma

Eligibility Criteria

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

Interventions

  • BGB-B2033 — DRUG
    Administered by intravenous infusion
  • Tislelizumab — DRUG
    Administered by intravenous infusion
  • Bevacizumab — DRUG
    Administered by intravenous infusion

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BGB-B2033 alone or in combination with tislelizumab, with or without bevacizumab, in adults with advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors, non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC). The study will also determine the recommended Phase 2 dose (RP2D) of BGB-B2033 when given alone or in combination with tislelizumab and bevacizumab. The main questions it aims to answer are: * Is BGB-B2033 safe and tolerable when given alone or in combination with tislelizumab, with or without bevacizumab? * How does the body process BGB-B2033, and what are its effects on the body? * Does BGB-B2033 show preliminary antitumor activity in participants with advanced or metastatic cancer? Researchers will evaluate different doses and treatment combinations to determine the safest and most appropriate dose of BGB-B2033 for further study. Participants will: * Receive BGB-B2033 by intravenous infusion, either alone or in combination with tislelizumab, with or without bevacizumab. * Have regular assessments to monitor safety, side effects, how their body processes and responds to BGB-B2033, and whether their cancer responds to treatment.

Key Dates

First listed
May 24, 2024
Start date
Jul 23, 2024
Status verified
Sep 2026
Primary completion
Mar 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
630 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (Monotherapy Dose Escalation and Safety Expansion)
    Participants will receive ascending dose levels of BGB-B2033 monotherapy
  • Experimental: Part B (Doublet Run-in)
    Participants will receive BGB-B2033 in combination with tislelizumab and to inform the starting dose of BGB-B2033 for subsequent triplet dose escalation.
  • Experimental: Part B (Triplet Dose Escalation)
    Participants will receive BGB-B2033 in combination with tislelizumab and bevacizumab to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), and recommended dose for expansion (RDFE) of the combination.
  • Experimental: Part B (Triplet and Doublet Safety Expansion)
    Safety expansion arm for each combination therapy cohort (triplet and doublet)
  • Experimental: Part C (Asia Monotherapy Dose Expansion in HCC)
    Participants in Asian countries with HCC will receive BGB-B2033 as monotherapy.
  • Experimental: Part D (US Monotherapy Dose Expansion in HCC)
    Participants in the United States (US) with HCC will receive BGB-B2033 as monotherapy.
  • Experimental: Part E (Monotherapy Dose Expansion in HCC)
    Participants with HCC will receive BGB-B2033 as monotherapy.

Primary Outcome Measure

Part A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2 years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama At Birmingham HospitalBirminghamAlabama35294-0004-
City of Hope Phoenix Cancer CenterGoodyearArizona85338-
City of Hope National Medical CenterDuarteCalifornia91010-3012-
City of Hope Chicago Cancer CenterZionIllinois60099-
Memorial Sloan Kettering Cancer Center MskccNew YorkNew York10065-6800-
Upmc Hillman Cancer Center(Univ of Pittsburgh)PittsburghPennsylvania15232-1309-
Scri Oncology PartnersNashvilleTennessee37203-1503-
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-4009-

Find similar trials in Birmingham, AL

By research site
University of Alabama At Birmingham Hospital· Birmingham, ALCity of Hope Phoenix Cancer Center· Goodyear, AZCity of Hope National Medical Center· Duarte, CACity of Hope Chicago Cancer Center· Zion, ILMemorial Sloan Kettering Cancer Center Mskcc· New York, NYUpmc Hillman Cancer Center(Univ of Pittsburgh)· Pittsburgh, PA

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