NCT07836530 Study Comparing BGB-B2033 With Sorafenib or Lenvatinib in Advanced Hepatocellular Carcinoma
| NCT ID | NCT07836530 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | BeOne Medicines |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 492 participants |
| Start Date | 2026-10-23 |
| Primary Completion | 2029-09-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 492 participants in total. It began in 2026-10-23 with a primary completion date of 2029-09-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn how well BGB-B2033 works and how safe it is in people with hepatocellular carcinoma (HCC) who have previously received up to two treatments that included programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) medicines. Researchers will compare BGB-B2033 with either sorafenib or lenvatinib chosen by the study doctor to see which treatment works better and is safer. The main questions it aims to answer are: * Does BGB-B2033 help control or slow the growth of liver cancer? * What medical problems or side effects do participants have while taking BGB-B2033? * Does BGB-B2033 help to prolong the survival for liver cancer participants over Lenvatinib/sorafenib?
Eligibility Criteria
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.
Contact & Investigator
Study Director
STUDY DIRECTOR
BeOne Medicines
Frequently Asked Questions
Who can join the NCT07836530 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07836530 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 492 participants.
Is NCT07836530 currently recruiting?
Yes, NCT07836530 is actively recruiting participants. Contact the research team at clinicaltrials@beonemed.com for enrollment information.
Where is the NCT07836530 trial being conducted?
This trial is being conducted at South Brisbane, Australia, Grafton, New Zealand.
Who is sponsoring the NCT07836530 clinical trial?
NCT07836530 is sponsored by BeOne Medicines. The principal investigator is Study Director at BeOne Medicines. The trial plans to enroll 492 participants.
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