Testing BGB-B2033 alone or with Tislelizumab for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-B2033 in patients with advanced or metastatic solid tumors, including hepatocellular carcinoma and GPC3-positive squamous non-small cell lung cancer. The study consists of two parts: monotherapy dose escalation and safety expansion, and combination therapy with Tislelizumab. Participants will receive BGB-B2033 via intravenous infusion, and the study aims to determine the recommended Phase 2 dose for future research.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Participants must have one of the following unresectable, locally advanced, or metastatic tumor types:

   1. Hepatocellular carcinoma (HCC): Histologically or cytologically confirmed HCC that is either Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not amenable to, or has progressed after, loco-regional therapy and is not eligible for a curative treatment approach.
   2. Alpha-fetoprotein (AFP)-producing gastric cancer (GC): Histologically confirmed GC with AFP \> 20 ng/mL in blood or tumor tissue positive for AFP by a validated immunohistochemistry (IHC) assay based on local or central testing.
   3. Germ cell tumors: Histologically confirmed germ cell tumors including extragonadal yolk sac tumors (e.g., located in the mediastinum, vagina, brain, retroperitoneum), and non-dysgerminomas for which no further curative systemic treatment options exist.
   4. Glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC): Histologically confirmed GPC3-positive squamous NSCLC with prior exposure to a checkpoint inhibitor (CPI).
2. At least one evaluable lesion for dose escalation, and at least one measurable lesion for safety expansion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
4. Adequate organ function as defined in the protocol.
5. Provision of tumor tissue samples is required for specified parts of the study.

Key Exclusion Criteria:

1. Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137).
2. Active leptomeningeal disease or uncontrolled/untreated brain metastases.
3. Active autoimmune disease or a history of autoimmune disease with potential for relapse.
4. Any malignancy diagnosed ≤ 2 years before the first dose of study drug(s), except: The cancer type under investigation in this study, or Locally recurring malignancies previously treated with curative intent.
5. Requirement for systemic corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to the first dose of study drug(s).
6. Certain comorbidities involving the lungs, heart, bleeding conditions, or active infections, as defined in the protocol.

Note: Additional protocol-defined inclusion and exclusion criteria may apply.

Where it's running

• University of Alabama At Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• City of Hope Phoenix Cancer Center
  Goodyear, Arizona, United States Recruiting
• City of Hope National Medical Center
  Duarte, California, United States Recruiting
• City of Hope Chicago Cancer Center
  Zion, Illinois, United States Recruiting
• Memorial Sloan Kettering Cancer Center Mskcc
  New York, New York, United States Recruiting
• Upmc Hillman Cancer Center(Univ of Pittsburgh)
  Pittsburgh, Pennsylvania, United States Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1.877.828.5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.