OncoMatch/Clinical Trials/NCT06427941
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
Official title: A Phase 1/2 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors
Is NCT06427941 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including BGB-B2033 and Tislelizumab for metastatic hepatocellular carcinoma.
Treatment: BGB-B2033 · Tislelizumab · Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Hepatocellular Carcinoma
Gastric Cancer
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: AFP expression (> 20 ng/mL in blood or tumor tissue positive for AFP by IHC)
AFP > 20 ng/mL in blood or tumor tissue positive for AFP by a validated immunohistochemistry (IHC) assay
Required: GPC3 expression (positive)
Glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: checkpoint inhibitor — squamous NSCLC
prior exposure to a checkpoint inhibitor (CPI)
Cannot have received: GPC3-targeted therapy
Prior therapy directed against glypican-3 (GPC3)
Cannot have received: CD137-targeted therapy
Prior therapy directed against ... the T-cell costimulatory receptor 4-1BB (CD137)
Lab requirements
Blood counts
Adequate organ function as defined in the protocol.
Kidney function
Adequate organ function as defined in the protocol.
Liver function
Adequate organ function as defined in the protocol.
Adequate organ function as defined in the protocol.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Phoenix Cancer Center · Goodyear, Arizona
- City of Hope National Medical Center · Duarte, California
- City of Hope Chicago Cancer Center · Zion, Illinois
- Memorial Sloan Kettering Cancer Center Mskcc · New York, New York
- Upmc Hillman Cancer Center(Univ of Pittsburgh) · Pittsburgh, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06427941 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior GPC3-targeted therapy, CD137-targeted therapy disqualifies patients from enrollment.
Does this trial require AFP?
Yes, AFP expression is a required biomarker for enrollment.
Does this trial require GPC3?
Yes, GPC3 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages