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NCT07043400PHASE3Recruiting

A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

BeOne Medicines

Start Date

8/27/2025

Completion Date

4/22/2028

Summary

This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma. * No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. * At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment. * Must be able to provide tumor tissues for biomarker assessment. * Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1. * Adequate organ function. * Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab. * Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab. Exclusion Criteria: * Squamous cell or undifferentiated or other histological type gastric cancer (GC) * Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization. * Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2). * Active autoimmune diseases or history of autoimmune diseases that may relapse. * Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

Subcutaneous Tislelizumab

DRUG

Intravenous Tislelizumab

DRUG

Cisplatin

DRUG

Leucovorin

DRUG

5-fluorouracil (5-FU)

DRUG

Oxaliplatin

DRUG

Capecitabine

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Metastatic Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

Locations

Ironwood Cancer and Research Centers Chandler Ii

Chandler, Arizona 85224-5665

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California 90720

United States

UC Health Cancer Care and Hematology Clinic Memorial Hospital Central

Colorado Springs, Colorado 80909

United States

Bioresearch Partners Holding Hialeah Hospital

Hialeah, Florida 33013-3804

United States

Orlando Health Cancer Institute Downtown Orlando

Orlando, Florida 32806

United States

Northwestern University

Chicago, Illinois 60611

United States

Hope and Healing Cancer Services

Hinsdale, Illinois 60521-0509

United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas 66160-8500

United States

New England Cancer Specialists

Westbrook, Maine 04092

United States

St Louis Cancer Care, Llp

Bridgeton, Missouri 63044

United States

Nebraska Hematology Oncology

Lincoln, Nebraska 68506-7548

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89169-3321

United States

Hunterdon Hematology Oncology

Flemington, New Jersey 08822-4603

United States

Summit Medical Group

Florham Park, New Jersey 07932-1049

United States

Oregon Oncology Specialists

Salem, Oregon 97301

United States

Vanderbilt University

Nashville, Tennessee 37232

United States

Md Anderson Cancer Center

Houston, Texas 77030-3907

United States

Scott and White Memorial Hospital

Temple, Texas 76508-0001

United States

Northwest Medical Specialties

Tacoma, Washington 98405

United States

Hospital Aleman

CABA, 1425

Argentina

Instituto Alexander Fleming (Iaf)

Ciudad Autonoma Buenos Aires, 1426

Argentina

Fundacion Cori Para La Investigacion Y Prevencion Del Cancer

La Rioja, F5300COE

Argentina

Krankenhaus Der Barmherzigen Schwestern Linz

Linz, 4010

Austria

Medical Univeristy Vienna

Vienna, 1090

Austria

Hospital de Amor Barretos

Barretos, 14784-400

Brazil

CECAP

Blumenau, 89035-510

Brazil

Hospital Brasilia

Brasília, 71681-603

Brazil

Hospital Universiario Onofre Lopes

Natal, 59012-300

Brazil

Hospital Sao Lucas Da Pucrs

Porto Alegre, 90610-000

Brazil

IMIP

Recife, 50070-902

Brazil

Inca Instituto Nacional de Cancer

Rio de Janeiro, 20231-050

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

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, 01401-004

Brazil

Hospital Santa Rita de Cassia Afecc

Vitória, 29043-260

Brazil

The Second Hospital of Anhui Medical University

Hefei, Anhui 230601

China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality 100021

China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian 361003

China

Anyang Tumor Hospital

Anyang, Henan 455001

China

Henan Cancer Hospital

Zhengzhou, Henan 450000

China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan 450052

China

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu 210008

China

Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University

Ganzhou, Jiangxi 341000

China

The First Hospital of China Medical University

Shenyang, Liaoning 110001

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China

Affiliated Hospital of Jining Medical University

Jining, Shandong 272000

China

Changzhi Peoples Hospital

Changzhi, Shanxi 046099

China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi 030013

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325000

China

Masarykuv Onkologicky Ustav

Brno, 602 00

Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 03

Czechia

Fakultni Nemocnice Olomouc

Olomouc, 77900

Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, 10000

Czechia

Institut Sainte Catherine

Avignon, 84000

France

Chru de Brest Hopital Cavale Blanche

Brest, 29200

France

Hopital Claude Huriez Chu Lille

Lille, 59000

France

Irccs Azienda Ospedaliera Metropolitana (Aom)

Genova, 16132

Italy

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133

Italy

Aou Pisana, Stabilimento Di Santa Chiara

Pisa, 56126

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Matsuyama Red Cross Hospital

Matsuyama, Ehime 790 8524

Japan

Japan Community Health Care Organization Kyushu Hospital

Kitakyushu, Fukuoka 806-0034

Japan

Nho Hokkaido Cancer Center

Sapporo, Hokkaido 003-0804

Japan

Osaka Rosai Hospital

SakaiShi, Osaka 591-8025

Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsukishi, Osaka 569-8686

Japan

Saitama Cancer Center

Kitaadachigun, Saitama 362-0806

Japan

Hamamatsu University School of Medicine, University Hospital

Hamamatsushi, Shizuoka 431-3192

Japan

Tochigi Cancer Center

Utsunomiya, Tochigi 320-0834

Japan

Institute of Science Tokyo Hospital

Bunkyoku, Tokyo 113-8519

Japan

Tokyo Metropolitan Bokutoh Hospital

SumidaKu, Tokyo 130-8575

Japan

Health Pharma Professional Research Sa de Cv

Mexico City, 03100

Mexico

Medical Care and Research Sa de Cv

Mérida, 97070

Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, 68020

Mexico

Pratia McM Krakow

Krakow, 30-727

Poland

Opolskie Centrum Onkologii

Opole, 45-061

Poland

Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie

Warsaw, 02-781

Poland

Pan American Oncology Trials, Llc

Rio Piedras, 00935

Puerto Rico

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Kyungpook National University Chilgok Hospital

BukGu, Gyeongsangbukdo 41404

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

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Hospital Universitario de Navarra

Pamplona, 31008

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

Hospital Universitario Miguel Servet

Zaragoza, 50009

Spain

Medical Park Seyhan Hospital

Adana, 01060

Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, 06200

Turkey (Türkiye)

Acibadem Adana Hospital

Kuruköprü, 01060

Turkey (Türkiye)

Medical Park Florya Hospital

Sefaköy, 34295

Turkey (Türkiye)

Cambridge University Hospitals Nhs Foundation Trust

Cambridge, CB2 0QQ

United Kingdom

Ninewells Hospital and Medical School

Dundee, DD1 9SY

United Kingdom

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, CH63 4JY

United Kingdom