Trial comparing treatments for Hepatocellular Carcinoma
Official title Study Comparing BGB-B2033 With Sorafenib or Lenvatinib in Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT07836530
What this study is testing
What is BGB-B2033?
BGB-B2033 is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically confirmed Hepatocellular Carcinoma (HCC) that is not amenable to curative surgical or locoregional therapies.
- Participants must have documented disease progression or intolerance after at least 1 but not exceeding 2 prior lines of systemic therapy containing...
- Glypican-3 (GPC3) expression level must be known for stratification.
- Participants must have at least 1 measurable lesion as assessed by RECIST v1.1
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. Key
You likely can't join if
- Prior therapy targeting GPC3 or 4-1BB
- Participants not feasible to be treated with lenvatinib or sorafenib
- prior exposure to both medications
- significant precautions of administering lenvatinib or sorafenib such as clinically significant active bleeding within 3 months prior to first dose...
- any history of gastrointestinal perforation or larger than grade 3 fistula within 6 months prior to the first dose,
- or any history of heart failure meeting NYHA classification III or IV ≤ 6 months before the first dose of study drug.
See the full eligibility criteria
- Participants must have histologically confirmed Hepatocellular Carcinoma (HCC) that is not amenable to curative surgical or locoregional therapies.
- 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...
- Glypican-3 (GPC3) expression level must be known for stratification.
- Participants must have at least 1 measurable lesion as assessed by RECIST v1.1
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. Key
- Prior therapy targeting GPC3 or 4-1BB
- Participants not feasible to be treated with lenvatinib or sorafenib
- prior exposure to both medications
- 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...
- any history of gastrointestinal perforation or larger than grade 3 fistula within 6 months prior to the first dose,
- or any history of heart failure meeting NYHA classification III or IV ≤ 6 months before the first dose of study drug.
- Active leptomeningeal disease or uncontrolled and untreated brain metastasis
- History of previous or present encephalopathy
- Presence of clinically significant ascites ((≥ Grade 2).
- History of liver transplantation NOTE: Other eligibility criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- South Brisbane, Queensland, Australia
- Grafton, Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at South Brisbane, Queensland, Australia; Grafton, Auckland, New Zealand. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.