Recruiting

Phase 3

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

Sponsor:

BeOne Medicines

Code:

NCT07043400

Conditions

Metastatic Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Subcutaneous Tislelizumab

Intravenous Tislelizumab

Cisplatin

Leucovorin

5-fluorouracil (5-FU)

Study Details

Brief 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.

Conditions

Metastatic Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Study ID

NCT07043400

Start date

Aug 27, 2025

Status verified date

Aug, 2026

Completion date

Apr 22, 2028

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

351 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Tislelizumab Subcutaneous + Chemotherapy

Participants will receive tislelizumab 300 mg subcutaneous (SC) injection on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.

active comparator: Arm B: Tislelizumab Intravenous Infusion + Chemotherapy

Participants will receive tislelizumab 200 mg intravenous infusion (IV) on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.

Interventions

Subcutaneous Tislelizumab

Administered by subcutaneous injection

Intravenous Tislelizumab