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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

RecruitingPhase 3

A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: BeOne Medicines · Participants: 351 · Started: Aug 27, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07043400

Locations in the U.S.

ArizonaIronwood Cancer and Research Centers Chandler Ii, Chandler
CaliforniaCancer and Blood Specialty Clinic, Los Alamitos
ColoradoUC Health Cancer Care and Hematology Clinic Memorial Hospital Central, Colorado Springs
FloridaBioresearch Partners Holding Hialeah Hospital, Hialeah
Orlando Health Cancer Institute Downtown Orlando, Orlando
IllinoisNorthwestern University, Chicago
Hope and Healing Cancer Services, Hinsdale
KansasUniversity of Kansas Medical Center Research Institute, Kansas City
MaineNew England Cancer Specialists, Westbrook
MissouriSt Louis Cancer Care, Llp, Bridgeton
NebraskaNebraska Hematology Oncology, Lincoln
NevadaComprehensive Cancer Centers of Nevada, Las Vegas
New JerseyHunterdon Hematology Oncology, Flemington
Summit Medical Group, Florham Park
OregonOregon Oncology Specialists, Salem
TennesseeVanderbilt University, Nashville
TexasThe University of Texas Md Anderson Cancer Center, Houston
Scott and White Memorial Hospital, Temple
WashingtonNorthwest Medical Specialties, Tacoma

From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.