A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States

August 21, 2026 updated by: BeOne Medicines

An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients

The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unresectable or metastatic gastric or gastroesophageal cancer (GAC/GEA) or esophageal squamous cell carcinoma (ESCC). The study duration will be up to approximately 6 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Study Director
Phone Number: 1-877-828-5568
Email: clinicaltrials@beonemed.com

Study Locations

United States
- California
  - Cerritos, California, United States, 90703
    - Recruiting
    - Helios Clinical Research
  - Los Angeles, California, United States, 90017-4803
    - Recruiting
    - Los Angeles Cancer Network
- Florida
  - Coral Springs, Florida, United States, 33065
    - Recruiting
    - Brcr Coral Springs
  - Hialeah, Florida, United States, 33013-3804
    - Recruiting
    - Bioresearch Partners Holding Hialeah Hospital
  - Plantation, Florida, United States, 33322
    - Recruiting
    - Florida Clinical Trials Group Plantation
  - Tamarac, Florida, United States, 33321
    - Recruiting
    - Florida Clinical Trials Group Tamarac
- Missouri
  - St Louis, Missouri, United States, 63110-1010
    - Recruiting
    - Washington University School of Medicine
- Ohio
  - Canton, Ohio, United States, 44718-2566
    - Recruiting
    - Gabrail Cancer Center Research

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.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Self-identifies as a member of racial and/or ethnic minority populations as defined by the Food and Drug Administration (FDA), such as Black or African American, Hispanic or Latino, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander
Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma (GAC/GEA) or esophageal squamous cell carcinoma (ESCC)
No previous systemic therapy for locally advanced unresectable or metastatic GAC/GEA or ESCC
At least 1 measurable lesion per RECIST v1.1 as determined by investigator assessment
Patients must have positive tumor programmed death-ligand 1 (PD-L1) expression. Documented PD-L1 results are acceptable
Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1
Adequate organ function as indicated by the following laboratory values ≤ 14 days prior to study treatment
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 and ≥ 180 days after the last dose of chemotherapy, and have a negative urine or serum pregnancy test ≤ 7 days prior to study treatment
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 and ≥ 180 days after the last dose of chemotherapy

Exclusion Criteria:

Patient has squamous cell or undifferentiated or other histological type gastric cancer
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 study treatment.
Patients with evidence of esophageal/bronchial or esophageal/aorta fistula, or complete esophageal obstruction not amenable to treatment.
Diagnosed with GAC/GEA with positive human epidermal growth factor receptor 2 (HER2). Results of the tumor HER2 testing must be known prior to study treatment
Active autoimmune diseases or history of autoimmune diseases that may relapse Note: Patients with the following diseases are not excluded and may proceed to further screening:
1. Controlled Type I diabetes
2. Hypothyroidism (provided it is managed with hormone replacement therapy only)
3. Controlled celiac disease
4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
5. Any other disease that is not expected to recur in the absence of external triggering factors
Any active malignancy ≤ 2 years before study treatment, with the exception of the specific cancer under investigation in this trial or any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to study treatment (the cytological confirmation of any effusion is permitted)
Have clinically significant bleeding (Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2) from the GI tract within 1 month prior to study treatment
Have a history of gastrointestinal (GI) perforation (CTCAE ≥ Grade 2) and/or fistulae (including prior gastric fistula operation) within 6 months prior to study treatment
Have a clinically significant bowel obstruction (CTCAE ≥ Grade 2)
Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before study treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastric / Gastroesophageal Adenocarcinoma (GAC/GEA) Participants will receive tislelizumab (either 200 mg every 3 weeks or 150 mg every 2 weeks, matching the chemotherapy regimen) and one of the following chemotherapy regimens: FOLFOX: oxaliplatin 85 mg + leucovorin on Day 1, followed by 5-fluorouracil (5-FU) (2400 to 2800 mg) IV, repeated every 2 weeks (Q2W). CAPOX: oxaliplatin 130 mg Day 1 + capecitabine 1000 mg orally twice daily for consecutive 14 days, repeated every 3 weeks (Q3W). Cisplatin 80 mg Day 1 + 5-FU 800 mg IV continuous infusion over 24 hours daily on Day 1 to Day 5, repeated Q3W.	Drug: Tislelizumab Administered by intravenous infusion Other Names: BGB-A317 Drug: Capecitabine Administered orally Drug: Leucovorin Administered by intravenous infusion Drug: 5-fluorouracil (5-FU) Administered by intravenous infusion Drug: Oxaliplatin Administered by intravenous infusion
Experimental: Esophageal Squamous Cell Carcinoma (ESCC) Participants will receive tislelizumab 150 mg Q2W and FOLFOX chemotherapy.	Drug: Tislelizumab Administered by intravenous infusion Other Names: BGB-A317 Drug: Leucovorin Administered by intravenous infusion Drug: 5-fluorouracil (5-FU) Administered by intravenous infusion Drug: Oxaliplatin Administered by intravenous infusion

Participant Group / Arm

Intervention / Treatment

Experimental: Gastric / Gastroesophageal Adenocarcinoma (GAC/GEA)

Participants will receive tislelizumab (either 200 mg every 3 weeks or 150 mg every 2 weeks, matching the chemotherapy regimen) and one of the following chemotherapy regimens:

FOLFOX: oxaliplatin 85 mg + leucovorin on Day 1, followed by 5-fluorouracil (5-FU) (2400 to 2800 mg) IV, repeated every 2 weeks (Q2W).
CAPOX: oxaliplatin 130 mg Day 1 + capecitabine 1000 mg orally twice daily for consecutive 14 days, repeated every 3 weeks (Q3W).
Cisplatin 80 mg Day 1 + 5-FU 800 mg IV continuous infusion over 24 hours daily on Day 1 to Day 5, repeated Q3W.

Drug: Tislelizumab