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RECRUITING

NCT06427941

PHASE1

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

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

392

Start Date

2024-07-23

Completion Date

2028-05-30

Last Updated

2026-07-08

Healthy Volunteers

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

Key Inclusion Criteria: 1. Participants must have one of the following unresectable, locally advanced, or metastatic tumor types: 1. 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. 2. 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. 3. 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. 4. 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). 2. At least one evaluable lesion for dose escalation, and 3. At least one measurable lesion for safety expansion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 5. Adequate organ function as defined in the protocol. 6. Provision of tumor tissue samples is required for specified parts of the study. Key Exclusion Criteria: 1. Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137). 2. Active leptomeningeal disease or uncontrolled/untreated brain metastases. 3. Active autoimmune disease or a history of autoimmune disease with potential for relapse. 4. 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. 5. 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). 6. 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.

Locations (47)

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

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Da Bahia

Salvador, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, Brazil

Anhui Provincial Hospital

Hefei, Anhui, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

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

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

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, China

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

Hopital Beaujon

Clichy, France

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, France

Institut Gustave Roussy

Villejuif, France

Irccs Istituto Nazionale Tumori Fondazione Pascale

Naples, Italy

Iov Istituto Oncologico Veneto Irccs

Padova, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Irccs Humanitas Research Hospital

Rozzano, Italy

Kindai University Hospital

Sakai, Osaka, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyoku, Tokyo, Japan

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo, Japan

Auckland City Hospital

Auckland, New Zealand

Hospital Oncologico

Rio Piedras, Puerto Rico

Chungbuk National University Hospital

Cheongju-si, Chungcheongbukdo, South Korea

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (47)