RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Metastatic Gastric Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Chandler

Ironwood Cancer and Research Centers, Chandler, Arizona, United States, 85224-5665

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010-3012

Los Alamitos

Cancer and Blood Specialty Clinic, Los Alamitos, California, United States, 90720-3302

Colorado Springs

University of Colorado Health Memorial Hospital, Colorado Springs, Colorado, United States, 80909-4501

Hialeah

Bioresearch Partners Holding Hialeah Hospital, Hialeah, Florida, United States, 33013-3804

Orlando

Orlando Health Ufhealth Cancer Center, Orlando, Florida, United States, 32806-2134

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Hinsdale

Hope and Healing Cancer Services, Hinsdale, Illinois, United States, 60521-0509

Kansas City

University of Kansas Medical Center Research Institute, Kansas City, Kansas, United States, 66160-8500

Westbrook

New England Cancer Specialists, Westbrook, Maine, United States, 04092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2028-04-22