RecruitingPhase 1Phase 2NCT06427941

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

Sponsor

BeOne Medicines

Enrollment

630 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

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

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new cancer drug called BGB-B2033, given alone or combined with other immunotherapy drugs (tislelizumab and/or bevacizumab), in people with advanced or spread cancers. The cancers being studied include liver cancer, a type of stomach cancer that produces a protein called AFP, germ cell tumors, and a specific type of lung cancer that tests positive for a protein called GPC3. **You may be eligible if...** - You have one of these advanced cancers: liver cancer (hepatocellular carcinoma), AFP-producing stomach cancer, germ cell tumors with no remaining curative options, or GPC3-positive squamous lung cancer that has been treated with a checkpoint inhibitor - Your cancer cannot be surgically removed or has spread - You are in generally good health and able to carry out daily activities (ECOG 0–1) - You have at least one tumor that can be measured on scans - Your organ function (liver, kidneys, blood counts) is within acceptable ranges **You may NOT be eligible if...** - You have previously received a drug that targets GPC3 or the immune receptor 4-1BB - You have cancer that has spread to the lining of the brain (leptomeningeal disease) or uncontrolled brain metastases - You have an active autoimmune disease or a history of one likely to flare up - You have another cancer diagnosed in the past 2 years (with limited exceptions) - You require high-dose steroids or immunosuppressants - You have significant lung, heart, or bleeding conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-B2033

Administered by intravenous infusion

DRUGTislelizumab

Administered by intravenous infusion

DRUGBevacizumab

Administered by intravenous infusion

Locations(51)

University of Alabama At Birmingham Hospital

Birmingham, Alabama, United 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

Fundacao Pio Xii Hospital de Amor de Barretos

Barretos, Brazil

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

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

São Paulo, 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

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

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NCT06427941

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