NCT06427941

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 Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: BeOne Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
DRUG	BGB-B2033	Administered by intravenous infusion
DRUG	Tislelizumab	Administered by intravenous infusion
DRUG	Bevacizumab	Administered by intravenous infusion

Timeline

• Start date: 2024-07-23
• Primary completion: 2026-10-30
• Completion: 2026-12-31
• First posted: 2024-05-24
• Last updated: 2026-04-17

Locations

20 sites across 5 countries: United States, China, New Zealand, Puerto Rico, South Korea

Regulatory

• FDA-regulated drug study