Actively Recruiting
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
Led by BeOne Medicines · Updated on 2026-06-03
392
Participants Needed
46
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety, tolerability, how the body processes and responds to BGB-B2033, and its anti-tumor activity when given alone or with tislelizumab, with or without bevacizumab. This first-in-human study focuses on participants with advanced or metastatic solid tumors including hepatocellular carcinoma (HCC), alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors or non-dysgerminomas, and glypican-3-positive squamous non-small cell lung cancer (NSCLC). The study aims to understand these treatments in these specific cancers and is sponsored by BeOne Medicines. The study includes multiple parts: dose escalation of BGB-B2033 alone, combination treatments with tislelizumab and sometimes bevacizumab, and safety expansions for each therapy group. Participants receive the drugs by intravenous infusion. Different cohorts will evaluate dose levels to find the recommended dose for future studies, including groups in Asian countries and the United States focusing on HCC. This design helps assess the best doses and combinations to advance treatment understanding. Participants will undergo safety monitoring for adverse events and serious adverse events for up to approximately two years. Researchers will measure tumor responses through overall response rates assessed by independent review and investigators, duration of response, disease control rate, progression-free survival, and overall survival. Blood samples will be taken to study drug levels and immune responses. Tumor tissue samples are required for some parts. The study involves regular evaluations to monitor health, treatment effects, and laboratory measures throughout the participation period.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) meeting BCLC Stage C or BCLC Stage B not eligible for curative treatment
- Diagnosed with alpha-fetoprotein (AFP)-producing gastric cancer with AFP > 20 ng/mL or positive AFP tumor tissue
- Diagnosed with histologically confirmed germ cell tumors including extragonadal yolk sac tumors or non-dysgerminomas without further curative options
- Diagnosed with glypican-3 (GPC3)-positive squamous non-small cell lung cancer with prior checkpoint inhibitor exposure
- At least one evaluable lesion for dose escalation
- At least one measurable lesion for safety expansion per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function as defined in the protocol
- Provision of tumor tissue samples as required for specified study parts
You will not qualify if you...
- Prior therapy targeting glypican-3 (GPC3) or T-cell costimulatory receptor 4-1BB (CD137)
- Active leptomeningeal disease or uncontrolled/untreated brain metastases
- Active autoimmune disease or history of autoimmune disease with potential relapse
- Any malignancy diagnosed within 2 years before first study drug dose, except cancer under investigation or locally recurring malignancies treated with curative intent
- Requirement for systemic corticosteroids (> 10 mg/day prednisone or equivalent) or immunosuppressive therapy within 14 days before first study drug dose
- Certain lung, heart, bleeding conditions, or active infections as defined in the protocol
- Additional protocol-defined inclusion and exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive BGB-B2033 alone or in combination with tislelizumab and/or bevacizumab by intravenous infusion to evaluate safety, tolerability, and preliminary antitumor activity.
Repeated dosing visits as per trial schedule
Trial Site Locations
Total: 46 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
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Actively Recruiting
8
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil, 90110-270
Actively Recruiting
9
Hospital Da Bahia
Salvador, Brazil, 41810-011
Actively Recruiting
10
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
11
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
12
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
13
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350028
Actively Recruiting
14
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
15
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
16
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, China, 530201
Actively Recruiting
17
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
18
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
19
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
20
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
21
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
22
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
23
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
24
The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch
Nanchang, Jiangxi, China, 330038
Actively Recruiting
25
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, China, 610041
Actively Recruiting
26
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
27
Lishui Central Hospital
Lishui, Zhejiang, China, 323000
Actively Recruiting
28
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
29
Hopital Beaujon
Clichy, France, 92110
Actively Recruiting
30
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, France, 44000
Actively Recruiting
31
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
32
Irccs Istituto Nazionale Tumori Fondazione Pascale
Naples, Italy, 80131
Actively Recruiting
33
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Actively Recruiting
34
Irccs Humanitas Research Hospital
Rozzano, Italy, 20089
Actively Recruiting
35
Kindai University Hospital
Sakai, Osaka, Japan, 590-0197
Actively Recruiting
36
Tokyo Metropolitan Komagome Hospital
Bunkyoku, Tokyo, Japan, 113-8677
Actively Recruiting
37
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, Japan, 135-8550
Actively Recruiting
38
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
39
Hospital Oncologico
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
40
Chungbuk National University Hospital
Cheongju-si, Chungcheongbukdo, South Korea, 28644
Actively Recruiting
41
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, South Korea, 13496
Actively Recruiting
42
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
43
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
44
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
45
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
46
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
Research Team
S
Study Director
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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