NCT06427941RecruitingPhase 1/2
A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors
A Phase 1/2 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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BGB-B2033 alone or in combination with tislelizumab, with or without bevacizumab, in adults with 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). The study will also determine the recommended Phase 2 dose (RP2D) of BGB-B2033 when given alone or in combination with tislelizumab and bevacizumab. The main questions it aims to answer are: * Is BGB-B2033 safe and tolerable when given alone or in combination with tislelizumab, with or without bevacizumab? * How does the body process BGB-B2033, and what are its effects on the body? * Does BGB-B2033 show preliminary antitumor activity in participants with advanced or metastatic cancer? Researchers will evaluate different doses and treatment combinations to determine the safest and most appropriate dose of BGB-B2033 for further study. Participants will: * Receive BGB-B2033 by intravenous infusion, either alone or in combination with tislelizumab, with or without bevacizumab. * Have regular assessments to monitor safety, side effects, how their body processes and responds to BGB-B2033, and whether their cancer responds to treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 630 (estimated)
- First submitted
- 20 May 2024
- Start date
- 23 Jul 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- BeOne Medicines
- NCT number
- NCT06427941
- EU CT number
- 2025-524136-19-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 630
- From 23 Jul 2024 to the primary completion date, 31 Mar 2027
- 50 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137).
- Any malignancy diagnosed ≤ 2 years before the first dose of study drug(s), except: The cancer type under investigation in this study, or Locally recurring malignancies previously treated with curative intent.
- Requirement for systemic corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to the first dose of study drug(s).
Other illness
- Active leptomeningeal disease or uncontrolled/untreated brain metastases.
- Active autoimmune disease or a history of autoimmune disease with potential for relapse.
- Certain comorbidities involving the lungs, heart, bleeding conditions, or active infections, as defined in the protocol.
- Note: Additional protocol-defined inclusion and exclusion criteria may apply.
Who the study is looking for
- Participants must have one of the following unresectable, locally advanced, or metastatic tumor types:
- Hepatocellular carcinoma (HCC): Histologically or cytologically confirmed HCC that is either Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not amenable to, or has progressed after, loco-regional therapy and is not eligible for a curative treatment approach.
- Alpha-fetoprotein (AFP)-producing gastric cancer (GC): Histologically confirmed GC with AFP \> 20 ng/mL in blood or tumor tissue positive for AFP by a validated immunohistochemistry (IHC) assay based on local or central testing.
- Germ cell tumors: Histologically confirmed germ cell tumors including extragonadal yolk sac tumors (e.g., located in the mediastinum, vagina, brain, retroperitoneum), and non-dysgerminomas for which no further curative systemic treatment options exist.
- Glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC): Histologically confirmed GPC3-positive squamous NSCLC with prior exposure to a checkpoint inhibitor (CPI).
- At least one evaluable lesion for dose escalation, and at least one measurable lesion for safety expansion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Adequate organ function as defined in the protocol.
- Provision of tumor tissue samples is required for specified parts of the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacao Pio Xii Hospital de Amor de Barretos Coordinator of this site? Confirm its status | Barretos | Brazil | Recruiting |
| Centro Gaucho Integrado de Oncologia Hospital Mae de Deus Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital Da Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Recruiting |
| Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Sichuan Cancer Hospital and Institute Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Zhujiang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Lishui Central Hospital Coordinator of this site? Confirm its status | Lishui | China | Recruiting |
| The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Guangxi Medical University Cancer Hospital Wuxiang Branch Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Centre Hospitalier Universitaire Nantes Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| IOV - Istituto Oncologico Veneto IRCCS Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| IRCCS Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Tokyo Metropolitan Komagome Hospital Coordinator of this site? Confirm its status | Bunkyoku | Japan | Recruiting |
| Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Kōtoku | Japan | Recruiting |
| Kindai University Hospital Coordinator of this site? Confirm its status | Sakai | Japan | Recruiting |
| Cha Bundang Medical Center, Cha University Coordinator of this site? Confirm its status | BundangGu SeongnamSi | South Korea | Recruiting |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | GangnamGu | South Korea | Recruiting |
| Severance Hospital Yonsei University Health System Coordinator of this site? Confirm its status | SeodaemunGu | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | SongpaGu | South Korea | Recruiting |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| Hospital Oncologico Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Recruiting |
| University of Alabama At Birmingham Hospital Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| City of Hope Phoenix Cancer Center Coordinator of this site? Confirm its status | Goodyear | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center Mskcc Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Upmc Hillman Cancer Center(Univ of Pittsburgh) Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| City of Hope Chicago Cancer Center Coordinator of this site? Confirm its status | Zion | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.