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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

NCT06427941 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2026-05-14

No results posted yet for this 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).

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

DRUG

BGB-B2033

Administered by intravenous infusion

DRUG

Tislelizumab

Administered by intravenous infusion

DRUG

Bevacizumab

Administered by intravenous infusion

Sponsors & Collaborators

  • BeOne Medicines

    lead INDUSTRY

Principal Investigators

  • Study Director · BeOne Medicines

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-23
Primary Completion
2028-05-30
Completion
2028-05-30
FDA Drug
Yes

Countries

  • United States
  • China
  • France
  • Japan
  • New Zealand
  • Puerto Rico
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06427941 on ClinicalTrials.gov