A Phase 1 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 Goodyear, Arizona.

Sponsor
BeOne Medicines
Study ID
NCT06427941
Phase
PHASE1
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

This is a first-in-human (FIH) clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of BGB-B2033 administered as monotherapy and in combination with tislelizumab, with or without bevacizumab. The study will enroll participants with locally 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).

Key Dates

Start date
Jul 23, 2024
Status verified
Jun 2026
Primary completion
May 30, 2028
Completion
May 30, 2028

Study Design

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

Arms

  • Experimental: Part A (Monotherapy Dose Escalation and Safety Expansion)
    Ascending dose levels of BGB-B2033 monotherapy
  • Experimental: Part B (Doublet Run-in)
    A cohort designed to evaluate the safety and tolerability of 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)
    Cohorts evaluating 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
  • Experimental: Part D (US Monotherapy Dose Expansion in HCC)
    Participants in the United States (US) with HCC

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 (7)

FacilityCityStateZIPSite coordinators
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 Goodyear, AZ

By research site
City 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, PAScri Oncology Partners· Nashville, TN

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