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

Not Applicable

Not yet recruiting

• Conditions: Metastatic Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: Subcutaneous Tislelizumab; Drug: Intravenous Tislelizumab; Drug: Cisplatin; Drug: Leucovorin; Drug: 5-fluorouracil (5-FU); Drug: Oxaliplatin; Drug: Capecitabine

• Registration Number: NCT07043400
• Lead Sponsor: BeiGene

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Study Start: 2025-09-01
• Primary Completion: 2027-10-30
• Study Completion: 2028-04-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 351

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Tislelizumab Subcutaneous + Chemotherapy	Subcutaneous Tislelizumab	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.
Arm A: Tislelizumab Subcutaneous + Chemotherapy	Cisplatin	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.
Arm A: Tislelizumab Subcutaneous + Chemotherapy	Leucovorin	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.
Arm A: Tislelizumab Subcutaneous + Chemotherapy	5-fluorouracil (5-FU)	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.
Arm A: Tislelizumab Subcutaneous + Chemotherapy	Oxaliplatin	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.
Arm A: Tislelizumab Subcutaneous + Chemotherapy	Capecitabine	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.
Arm B: Tislelizumab Intravenous Infusion + Chemotherapy	Intravenous Tislelizumab	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.
Arm B: Tislelizumab Intravenous Infusion + Chemotherapy	Cisplatin	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.
Arm B: Tislelizumab Intravenous Infusion + Chemotherapy	Leucovorin	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.
Arm B: Tislelizumab Intravenous Infusion + Chemotherapy	5-fluorouracil (5-FU)	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.
Arm B: Tislelizumab Intravenous Infusion + Chemotherapy	Oxaliplatin	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.
Arm B: Tislelizumab Intravenous Infusion + Chemotherapy	Capecitabine	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.

Primary Outcome Measures

Name	Time	Method
Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab	85 Days
Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab	21 Days

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 2 years	ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Progression-Free Survival (PFS)	Up to 2 years	PFS is defined as the time from randomization date until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1
Duration of Response (DOR)	Up to 2 years	DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as assessed by the investigator using RECIST v1.1
Disease Control Rate (DCR)	Up to 2 years	DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1
Overall Survival (OS)	Up to 2 years	OS is defined as the time from first study drug administration to the date of death due to any cause
Number of Participants With Adverse Events (AEs)	Up to 2 years	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.
Model-predicted Serum Ctrough at Cycle 1	21 Days
Observed Serum Ctrough at Cycle 1	21 Days
Observed Area Under the Concentration-time Curve at Steady-state (AUC) at Cycle 1	21 Days
Model-predicted Area Under the Concentration-time Curve at Steady-state (AUCss)	85 Days
Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab after SC or IV Administration	Up to 2 years

Trial Locations

Locations (87)

Ironwood Cancer and Research Centers; 🇺🇸 Chandler, Arizona, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Cancer and Blood Specialty Clinic; 🇺🇸 Los Alamitos, California, United States

University of Colorado Health Memorial Hospital; 🇺🇸 Colorado Springs, Colorado, United States

Bioresearch Partners Holding Hialeah Hospital; 🇺🇸 Hialeah, Florida, United States

Orlando Health Ufhealth Cancer Center; 🇺🇸 Orlando, Florida, United States

Emory University Winship Cancer Center; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Hope and Healing Cancer Services; 🇺🇸 Hinsdale, Illinois, United States

University of Kansas Medical Center Research Institute; 🇺🇸 Kansas City, Kansas, United States

Scroll for more (77 remaining)