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Clinical Trials in the UK / NCT07043400
Recruiting Phase 3

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

NCT07043400 · tracked via the Priya Life Science UK tracker
Sponsor
BeOne Medicines
Phase
Phase 3
Started
2025-08-27
Last updated
2026-09-14

Condition(s) studied

Metastatic Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

Subcutaneous TislelizumabIntravenous TislelizumabCisplatinLeucovorin5-fluorouracil (5-FU)OxaliplatinCapecitabine

Subcutaneous Tislelizumab: Administered by subcutaneous injection

Intravenous Tislelizumab: Administered by intravenous infusion

Cisplatin: Administered by intravenous infusion

Leucovorin: Administered by intravenous infusion

5-fluorouracil (5-FU): Administered by intravenous infusion

Oxaliplatin: Administered by intravenous infusion

Capecitabine: Administered orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (95)

FacilityCityRegionStatus
Ironwood Cancer and Research Centers Chandler Ii Chandler Arizona Recruiting
Cancer and Blood Specialty Clinic Los Alamitos California Recruiting
UC Health Cancer Care and Hematology Clinic Memorial Hospital Central Colorado Springs Colorado Recruiting
Bioresearch Partners Holding Hialeah Hospital Hialeah Florida Recruiting
Orlando Health Cancer Institute Downtown Orlando Orlando Florida Recruiting
Northwestern University Chicago Illinois Recruiting
Hope and Healing Cancer Services Hinsdale Illinois Recruiting
University of Kansas Medical Center Research Institute Kansas City Kansas Recruiting
New England Cancer Specialists Westbrook Maine Recruiting
St Louis Cancer Care, Llp Bridgeton Missouri Recruiting
Nebraska Hematology Oncology Lincoln Nebraska Recruiting
Comprehensive Cancer Centers of Nevada Las Vegas Nevada Recruiting
Hunterdon Hematology Oncology Flemington New Jersey Recruiting
Summit Medical Group Florham Park New Jersey Recruiting
Oregon Oncology Specialists Salem Oregon Recruiting
Vanderbilt University Nashville Tennessee Recruiting
The University of Texas Md Anderson Cancer Center Houston Texas Recruiting
Scott and White Memorial Hospital Temple Texas Recruiting
Northwest Medical Specialties Tacoma Washington Recruiting
Hospital Aleman Caba Argentina Recruiting
Instituto Alexander Fleming (Iaf) Ciudad Autonoma Buenos Aires Argentina Recruiting
Fundacion Cori Para La Investigacion Y Prevencion Del Cancer La Rioja Argentina Recruiting
Krankenhaus Der Barmherzigen Schwestern Linz Linz Austria Recruiting
Medical Univeristy Vienna Vienna Austria Recruiting
Hospital de Amor Barretos Barretos Brazil Recruiting
CECAP Blumenau Brazil Recruiting
Hospital Brasilia Brasília Brazil Recruiting
Hospital Universiario Onofre Lopes Natal Brazil Recruiting
Hospital Sao Lucas Da Pucrs Porto Alegre Brazil Recruiting
IMIP Recife Brazil Recruiting
Inca Instituto Nacional de Cancer Rio de Janeiro Brazil Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto São José do Rio Preto Brazil Recruiting
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira São Paulo Brazil Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo São Paulo Brazil Recruiting
Hospital Santa Rita de Cassia Afecc Vitória Brazil Recruiting
The Second Hospital of Anhui Medical University Hefei Anhui Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
Anyang Tumor Hospital Anyang Henan Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting

+ 55 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07043400 on ClinicalTrials.gov ↗ ← All trials in the UK