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

Launched by BEIGENE · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a cancer treatment called tislelizumab for adults with advanced stomach cancer or cancer where the stomach meets the esophagus. The goal is to compare two ways of giving this medicine: as a shot under the skin (subcutaneous) versus through a vein (intravenous), both combined with chemotherapy. This study will help doctors understand how well the medicine works and how the body absorbs it when given in these different ways. About 351 patients who have cancer that cannot be removed by surgery or has spread to other parts of the body will take part in the trial.

To join the study, participants must have a confirmed diagnosis of this type of stomach cancer and have not yet received treatment for it. They need to be in reasonably good health and able to provide a small sample of their tumor for testing. Both men and women of childbearing age must agree to use effective birth control during and after the study. Participants will go through a screening process, receive treatment with tislelizumab plus chemotherapy, and be monitored afterward to see how they respond and how safe the treatment is. This trial is not yet recruiting patients, but it offers a chance to try a new way of receiving this cancer medicine that might be more convenient than traditional IV infusions.

Gender

ALL

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.