A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizum… (NCT06427941) | Clinical Trial Compass
RecruitingPhase 1
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
United States, China140 participantsStarted 2024-07-23
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants must have one of the following unresectable, locally advanced, or metastatic tumor types:
✓. 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.
✓. 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.
✓. 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.
✓. 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).
✓. 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.
✓
What they're measuring
1
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to approximately 2 years
2
Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033
. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Exclusion criteria
✕. Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137).
✕. Active leptomeningeal disease or uncontrolled/untreated brain metastases.
✕. Active autoimmune disease or a history of autoimmune disease with potential for relapse.
✕. 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.
✕. 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).
✕. Certain comorbidities involving the lungs, heart, bleeding conditions, or active infections, as defined in the protocol.