A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Advanced or Metastatic Solid Tumors

Launched by BEIGENE · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BGB-B2033, which is being tested alone and in combination with another medication called tislelizumab. The goal is to see how safe BGB-B2033 is, how well it works, and to determine the best dose for future studies. It is specifically looking at patients who have certain types of difficult-to-treat cancers, including advanced liver cancer, specific stomach cancers, and certain lung cancers.

To participate in this study, individuals need to have specific types of advanced or metastatic tumors and meet certain health criteria. For example, they should have at least one measurable tumor and good overall health, as assessed by their doctor. Participants will receive BGB-B2033 through an intravenous infusion, and the trial will be conducted in two parts to evaluate both the medication alone and in combination with tislelizumab. If you or someone you know is considering joining this trial, it’s a chance to help researchers learn more about a new treatment that could potentially benefit others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Participants with any of the following unresectable locally advanced or metastatic tumor types:
• • 1. HCC
• • 2. AFP-producing GC (serum AFP \> 20 ng/mL or tumor tissue AFP positive by a validated IHC assay according to local testing criteria)
• • 3. germ cell tumor including extragonadal yolk sac tumors (located in mediastinum, vagina, brain, and retroperitoneum, etc) and non-dysgerminomas
• • 4. GPC3-positive squamous NSCLC
• • 2. ≥ 1 evaluable lesion for dose escalation and ≥ 1 measurable lesion for safety expansion, per RECIST v1.1
• • 3. ECOG Performance Status score ≤ 1
• • 4. Adequate organ functions
• • 5. Tumor tissues will be required for certain parts of the study
• Exclusion Criteria:
• • 1. Prior therapy targeting glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (also known as CD137)
• • 2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
• • 3. Active autoimmune diseases or history of autoimmune diseases that may relapse
• • 4. Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
• • 5. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).
• • 6. Certain comorbidities in the lung, heart, bleeding condition and infections.
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.