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NCT06427941 · ClinicalTrials.gov registry record · Phase 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
A Phase 1 study of Metastatic Hepatocellular Carcinoma and Local Advanced Hepatocellular Carcinoma, sponsored by BeOne Medicines.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
- 19
- Study locations
NCT06427941: Recruiting Phase 1 study of Metastatic Hepatocellular Carcinoma and Local Advanced Hepatocellular Carcinoma, sponsored by BeOne Medicines.
NCT06427941 is a Phase 1 study of Metastatic Hepatocellular Carcinoma and Local Advanced Hepatocellular Carcinoma that is actively recruiting participants, run by BeOne Medicines. The registered enrollment target is 140 participants, above the 91-participant average among 11 other Metastatic Hepatocellular Carcinoma trials with a reported enrollment target (54% higher). The trial reports 19 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06427941, a Phase 1 study of Metastatic Hepatocellular Carcinoma and Local Advanced Hepatocellular Carcinoma, is actively recruiting participants, sponsored by BeOne Medicines.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
- 19
- Study locations
Study 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).
Primary Outcome
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0/American Society for Transplantation and Cellular Therapy \[ASTCT\] for cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\]), timing, seriousness, and relationship to study therapy; assessment of adverse events meeting protocol-defined dose-li
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Tislelizumab
- DRUG BGB-B2033
Study Locations (19)
Seoul Teugbyeolsi
- Samsung Medical Center - GangnamGu
- Severance Hospital Yonsei University Health System - SeodaemunGu
- Seoul National University Hospital - Seoul
Jiangxi
- The Second Affiliated Hospital of Nanchang University - Nanchang
- The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch - Nanchang
Other
- Auckland City Hospital - Auckland
- Hospital Oncologico - Rio Piedras
Gyeonggi-do
- Cha Bundang Medical Center, Cha University - BundangGu SeongnamSi
- Seoul National University Bundang Hospital - Seongnam-si
New York
- Memorial Sloan Kettering Cancer Center Mskcc - New York
Pennsylvania
- Upmc Hillman Cancer Center(Univ of Pittsburgh) - Pittsburgh
Tennessee
- Scri Oncology Partners - Nashville
Anhui
- Anhui Provincial Hospital - Hefei
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2024-07-23 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT06427941 shows while recruiting
NCT06427941 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 91-participant average among 11 other Metastatic Hepatocellular Carcinoma trials with a reported enrollment target (54% higher).
The record links to 5 conditions, with Metastatic Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT06427941 lists 19 locations in 14 states (Seoul Teugbyeolsi, Jiangxi, Other).
Frequently Asked Questions
What is clinical trial NCT06427941 about?
NCT06427941 is a clinical study titled "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". 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 partici...
What is the current status of trial NCT06427941?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2024-07-23. Estimated completion is 2026-12-31.
What conditions does trial NCT06427941 study?
This clinical trial studies the following conditions: Metastatic Hepatocellular Carcinoma, Local Advanced Hepatocellular Carcinoma, Alpha-fetoprotein (AFP)-Producing Gastric Cancer, Extragonadal Yolk Sac Tumors, Glypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer.
What interventions are being tested in trial NCT06427941?
The interventions under investigation include: Bevacizumab (DRUG), Tislelizumab (DRUG), BGB-B2033 (DRUG).
Who is sponsoring clinical trial NCT06427941?
This trial is sponsored by BeOne Medicines, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06427941 being conducted?
This trial has 19 study locations across New York, Pennsylvania, Tennessee, Anhui, Fujian. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06427941's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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