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

Phase 3RecruitingNCT07043400

BeOne Medicines351 enrolled

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.

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

351

Conditions

Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (65)

Ironwood Cancer and Research Centers

Chandler, Arizona, United States

RECRUITING

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

RECRUITING

Bioresearch Partners Holding Hialeah Hospital

Hialeah, Florida, United States

RECRUITING

Orlando Health Ufhealth Cancer Center

Orlando, Florida, United States

Outcomes

Primary Outcomes

Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab

Time frame: 85 Days

Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab

Time frame: 21 Days

Secondary Outcomes

Objective Response Rate (ORR)

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

Time frame: Up to 2 years

Progression-Free Survival (PFS)

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

Time frame: Up to 2 years

Duration of Response (DOR)

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

Time frame: Up to 2 years

Disease Control Rate (DCR)

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

Time frame: Up to 2 years

Overall Survival (OS)

OS is defined as the time from first study drug administration to the date of death due to any cause

Time frame: Up to 2 years

Number of Participants With Adverse Events (AEs)

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.

Time frame: Up to 2 years

Model-predicted Serum Ctrough at Cycle 1

Time frame: 21 Days

Observed Serum Ctrough at Cycle 1

Time frame: 21 Days

Observed Area Under the Concentration-time Curve at Steady-state (AUC) at Cycle 1

Time frame: 21 Days

Model-predicted Area Under the Concentration-time Curve at Steady-state (AUCss)

Time frame: 85 Days

Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab after SC or IV Administration

Time frame: Up to 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (65)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts