Actively Recruiting

Phase 1
Age: 18Years +
All Genders
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

Led by BeOne Medicines · Updated on 2026-05-14

392

Participants Needed

29

Research Sites

201 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have unresectable, locally advanced, or metastatic hepatocellular carcinoma (BCLC Stage C or Stage B not suitable for curative treatment)
  • Participants with alpha-fetoprotein-producing gastric cancer confirmed by blood level or tumor testing
  • Participants with histologically confirmed extragonadal yolk sac tumors or non-dysgerminomas with no curative options
  • Participants with glypican-3-positive squamous non-small cell lung cancer with prior checkpoint inhibitor treatment
  • At least one evaluable lesion for dose escalation and one measurable lesion for safety expansion
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate organ function as defined in the study protocol
  • Willingness to provide tumor tissue samples as required
Not Eligible

You will not qualify if you...

  • Prior treatment targeting glypican-3 (GPC3) or T-cell costimulatory receptor 4-1BB (CD137)
  • Active leptomeningeal disease or untreated/uncontrolled brain metastases
  • Active autoimmune disease or history of autoimmune disease with risk of relapse
  • Any malignancy diagnosed within 2 years before study drug except study cancer or locally recurring malignancy treated with curative intent
  • Need for systemic corticosteroids over 10 mg/day prednisone (or equivalent) or other immunosuppressive therapy within 14 days before first study drug dose
  • Certain lung, heart, bleeding conditions, or active infections as defined by protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 29 locations

1

City of Hope Phoenix Cancer Center

Goodyear, Arizona, United States, 85338

Actively Recruiting

2

City of Hope National Medical Center

Duarte, California, United States, 91010-3012

Actively Recruiting

3

City of Hope Chicago Cancer Center

Zion, Illinois, United States, 60099

Actively Recruiting

4

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States, 10065-6800

Actively Recruiting

5

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania, United States, 15232-1309

Actively Recruiting

6

Scri Oncology Partners

Nashville, Tennessee, United States, 37203-1503

Actively Recruiting

7

Anhui Provincial Hospital

Hefei, Anhui, China, 230000

Actively Recruiting

8

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350025

Actively Recruiting

9

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510515

Actively Recruiting

10

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, China, 530201

Actively Recruiting

11

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150000

Actively Recruiting

12

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430022

Actively Recruiting

13

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

Actively Recruiting

14

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Actively Recruiting

15

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330006

Actively Recruiting

16

The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch

Nanchang, Jiangxi, China, 330038

Actively Recruiting

17

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, China, 610041

Actively Recruiting

18

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

19

Lishui Central Hospital

Lishui, Zhejiang, China, 323000

Actively Recruiting

20

Hopital Beaujon

Clichy, France, 92110

Actively Recruiting

21

Kindai University Hospital

Sakai, Osaka, Japan, 590-0197

Actively Recruiting

22

Auckland City Hospital

Auckland, New Zealand, 1023

Actively Recruiting

23

Hospital Oncologico

Rio Piedras, Puerto Rico, 00935

Actively Recruiting

24

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do, South Korea, 13496

Actively Recruiting

25

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

26

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea, 06351

Actively Recruiting

27

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722

Actively Recruiting

28

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Actively Recruiting

29

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea, 05505

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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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 | DecenTrialz