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
Recruiting · NCT06427941 · Interventional (participants receive a specific treatment) · Lead sponsor: BeOne Medicines
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Key
Exclusion criteria
- Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137).
- Active leptomeningeal disease or uncontrolled/untreated brain metastases.
- Active autoimmune disease or a history of autoimmune disease with potential for relapse.
- 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).
- 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.
Where it is running
49 locations listed across 7 US states.
- City of Hope Phoenix Cancer Center - Goodyear, Arizona, United States
- City of Hope National Medical Center - Duarte, California, United States
- City of Hope Chicago Cancer Center - Zion, Illinois, United States
- Memorial Sloan Kettering Cancer Center Mskcc - New York, New York, United States
- Upmc Hillman Cancer Center(Univ of Pittsburgh) - Pittsburgh, Pennsylvania, United States
- Scri Oncology Partners - Nashville, Tennessee, United States
- The University of Texas Md Anderson Cancer Center - Houston, Texas, United States
- Auckland City Hospital - Auckland, New Zealand
- Fundacao Pio Xii Hospital de Amor de Barretos - Barretos, Brazil
- Hopital Beaujon - Clichy, France
- Centre Hospitalier Universitaire Nantes Hotel Dieu - Nantes, France
- Irccs Istituto Nazionale Tumori Fondazione Pascale - Naples, Italy
- Iov Istituto Oncologico Veneto Irccs - Padova, Italy
- Centro Gaucho Integrado de Oncologia Hospital Mae de Deus - Porto Alegre, Brazil
- Hospital Oncologico - Rio Piedras, Puerto Rico
- Fondazione Policlinico Universitario Agostino Gemelli - Roma, Italy
- Irccs Humanitas Research Hospital - Rozzano, Italy
- Hospital Da Bahia - Salvador, Brazil
- Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto - São José do Rio Preto, Brazil
- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira - São Paulo, Brazil
- Institut Gustave Roussy - Villejuif, France
- Anhui Provincial Hospital - Hefei, Anhui, China
- Chongqing University Cancer Hospital - Chongqing, Chongqing Municipality, China
- Chungbuk National University Hospital - Cheongju-si, Chungcheongbukdo, South Korea
- Mengchao Hepatobiliary Hospital of Fujian Medical University - Fuzhou, Fujian, China
- Zhujiang Hospital of Southern Medical University - Guangzhou, Guangdong, China
- Nanfang Hospital of Southern Medical University - Guangzhou, Guangdong, China
- Guangxi Medical University Cancer Hospital Wuxiang Branch - Nanning, Guangxi, China
- Cha Bundang Medical Center, Cha University - BundangGu SeongnamSi, Gyeonggi-do, South Korea
- Seoul National University Bundang Hospital - Seongnam-si, Gyeonggi-do, South Korea
- The Fourth Hospital of Hebei Medical University - Shijiazhuang, Hebei, China
- Harbin Medical University Cancer Hospital - Harbin, Heilongjiang, China
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology - Wuhan, Hubei, China
- Hunan Cancer Hospital - Changsha, Hunan, China
- The Affiliated Hospital of Xuzhou Medical University - Xuzhou, Jiangsu, China
- The Second Affiliated Hospital of Nanchang University - Nanchang, Jiangxi, China
- The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch - Nanchang, Jiangxi, China
- Kindai University Hospital - Sakai, Osaka, Japan
- Samsung Medical Center - GangnamGu, Seoul Teugbyeolsi, South Korea
- Severance Hospital Yonsei University Health System - SeodaemunGu, Seoul Teugbyeolsi, South Korea
- Seoul National University Hospital - Seoul, Seoul Teugbyeolsi, South Korea
- Asan Medical Center - SongpaGu, Seoul Teugbyeolsi, South Korea
- Sichuan Cancer Hospital and Institute - Chengdu, Sichuan, China
- Tokyo Metropolitan Komagome Hospital - Bunkyoku, Tokyo, Japan
- Cancer Institute Hospital of Jfcr - Kotoku, Tokyo, Japan
- The First Affiliated Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
- Lishui Central Hospital - Lishui, Zhejiang, China
- The First Affiliated Hospital of Wenzhou Medical University - Wenzhou, Zhejiang, China