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NCT06427941PHASE1Recruiting

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

BeOne Medicines

Start Date

7/23/2024

Completion Date

5/30/2028

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BGB-B2033

DRUG

Tislelizumab

DRUG

Bevacizumab

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Conditions

Metastatic Hepatocellular CarcinomaLocal Advanced Hepatocellular CarcinomaAlpha-fetoprotein (AFP)-Producing Gastric CancerExtragonadal Yolk Sac TumorsGlypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer

Locations

City of Hope Phoenix Cancer Center

Goodyear, Arizona 85338

United States

City of Hope National Medical Center

Duarte, California 91010-3012

United States

City of Hope Chicago Cancer Center

Zion, Illinois 60099

United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York 10065-6800

United States

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania 15232-1309

United States

Scri Oncology Partners

Nashville, Tennessee 37203-1503

United States

The University of Texas Md Anderson Cancer Center

Houston, Texas 77030-4009

United States

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, 90110-270

Brazil

Hospital Da Bahia

Salvador, 41810-011

Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, 15090-000

Brazil

Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

São Paulo, 01246-000

Brazil

Anhui Provincial Hospital

Hefei, Anhui 230000

China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality 400030

China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian 350028

China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong 510000

China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong 510515

China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi 530201

China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei 050011

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

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

Wuhan, Hubei 430022

China

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

Wuhan, Hubei 430030

China

Hunan Cancer Hospital

Changsha, Hunan 410013

China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu 221000

China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch

Nanchang, Jiangxi 330038

China

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan 610041

China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang 310003

China

Lishui Central Hospital

Lishui, Zhejiang 323000

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325000

China

Hopital Beaujon

Clichy, 92110

France

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, 44000

France

Institut Gustave Roussy

Villejuif, 94800

France

Irccs Istituto Nazionale Tumori Fondazione Pascale

Naples, 80131

Italy

Iov Istituto Oncologico Veneto Irccs

Padova, 35128

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Irccs Humanitas Research Hospital

Rozzano, 20089

Italy

Kindai University Hospital

Sakai, Osaka 590-0197

Japan

Tokyo Metropolitan Komagome Hospital

Bunkyoku, Tokyo 113-8677

Japan

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo 135-8550

Japan

Auckland City Hospital

Auckland, 1023

New Zealand

Hospital Oncologico

Rio Piedras, 00935

Puerto Rico

Chungbuk National University Hospital

Cheongju-si, Chungcheongbukdo 28644

South Korea

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do 13496

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi 06351

South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi 03722

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi 05505

South Korea