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

Recruiting now · Phase 3

Conditions studied: Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT07043400

Run by

BeOne Medicines

People needed

351

Starts

2025-08-27

Expected to finish

2028-04-22

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (enrolling)
• UC Health Cancer Care and Hematology Clinic Memorial Hospital Central — Colorado Springs, Colorado, United States (enrolling)
• Bioresearch Partners Holding Hialeah Hospital — Hialeah, Florida, United States (enrolling)
• Orlando Health Cancer Institute Downtown Orlando — Orlando, Florida, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Hope and Healing Cancer Services — Hinsdale, Illinois, United States (enrolling)
• University of Kansas Medical Center Research Institute — Kansas City, Kansas, United States (enrolling)
• New England Cancer Specialists — Westbrook, Maine, United States (enrolling)
• St Louis Cancer Care, Llp — Bridgeton, Missouri, United States (enrolling)
• Nebraska Hematology Oncology — Lincoln, Nebraska, United States (enrolling)
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States (enrolling)
• Hunterdon Hematology Oncology — Flemington, New Jersey, United States (enrolling)
• Summit Medical Group — Florham Park, New Jersey, United States (enrolling)
• Oregon Oncology Specialists — Salem, Oregon, United States (enrolling)
• Vanderbilt University — Nashville, Tennessee, United States (enrolling)
• Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Scott and White Memorial Hospital — Temple, Texas, United States (enrolling)
• Northwest Medical Specialties — Tacoma, Washington, United States (enrolling)
• Hospital Aleman — CABA, Argentina (enrolling)
• Instituto Alexander Fleming (Iaf) — Ciudad Autonoma Buenos Aires, Argentina (enrolling)
• Fundacion Cori Para La Investigacion Y Prevencion Del Cancer — La Rioja, Argentina (enrolling)
• Krankenhaus Der Barmherzigen Schwestern Linz — Linz, Austria (enrolling)
• Medical Univeristy Vienna — Vienna, Austria (enrolling)
• Hospital de Amor Barretos — Barretos, Brazil (enrolling)
• Ironwood Cancer and Research Centers Chandler Ii — Chandler, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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