BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer

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 3 trial compares BGB-B2033 to sorafenib or lenvatinib in adults with hepatocellular carcinoma who have progressed after up to two PD-1/PD-L1–based treatments. Participants are randomly assigned to receive intravenous BGB-B2033 or an approved oral therapy (sorafenib or lenvatinib) chosen by the investigator. The study aims to determine whether BGB-B2033 can better control tumor growth and extend survival, while monitoring safety and adverse events. The trial plans to enroll about 492 participants at multiple centers worldwide and requires measurable disease and adequate organ function. Glypican-3 expression is used for stratification, and participants must have an ECOG performance status of 0 or 1.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Participants must have histologically confirmed Hepatocellular Carcinoma (HCC) that is not amenable to curative surgical or locoregional therapies.
2. Participants must have documented disease progression or intolerance after at least 1 but not exceeding 2 prior lines of systemic therapy containing Programmed Cell Death Protein 1 / Programmed Death-Ligand 1 (PD-1/PD-L1). Prior cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) targeting therapy or v ascular endothelial growth factor (VEGF) is permitted but not required.
3. Glypican-3 (GPC3) expression level must be known for stratification.
4. Participants must have at least 1 measurable lesion as assessed by RECIST v1.1
5. Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.

Key Exclusion Criteria:

1. Prior therapy targeting GPC3 or 4-1BB
2. Participants not feasible to be treated with lenvatinib or sorafenib

   1. prior exposure to both medications
   2. significant precautions of administering lenvatinib or sorafenib such as clinically significant active bleeding within 3 months prior to first dose, tumor thrombus involving main portal vein trunk, inferior vena cava, or cardiac involvement,
   3. any history of gastrointestinal perforation or larger than grade 3 fistula within 6 months prior to the first dose,
   4. or any history of heart failure meeting NYHA classification III or IV ≤ 6 months before the first dose of study drug.
3. Active leptomeningeal disease or uncontrolled and untreated brain metastasis
4. History of previous or present encephalopathy
5. Presence of clinically significant ascites ((≥ Grade 2).
6. History of liver transplantation

NOTE: Other eligibility criteria may apply.

Where it's running

• Icon Cancer Centre South Brisbane
  South Brisbane, Queensland, Australia Recruiting
• Auckland City Hospital
  Grafton, Auckland, New Zealand Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1-877-828-5568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• PSMA PET-guided Lu-177 radioligand therapy for metastatic hepatocellular carcinoma.

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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.