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

StatusRecruiting

PhasePhase 2

SponsorBeOne Medicines

Started2026-04-30

View on ClinicalTrials.gov ↗

Amendment history

2026-08-21

Study Status, Contacts/Locations v5

Study sites6→8

2026-07-21

Study Status, Contacts/Locations v4

Study sites5→6

2026-07-08

Study Status, Contacts/Locations v3

Trial sites expanded: 2 → 5 locations

2026-06-18

Study Status, Contacts/Locations v2

Study sites1→2

2026-05-08

Study Status, Contacts/Locations v1

Recruitment opened

Start dateestimated 2026-09-01→confirmed 2026-04-30

Study sites0→1

2026-04-21

Original filing

BeOne Medicines

59 trials monitored

See 7 trials at risk

Gastric Cancer

1,194 trials monitored

See 60 trials at risk

Esophageal Cancer

1,010 trials monitored

See 51 trials at risk

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.

Trial Details

NCT Number	NCT07554521
Lead Sponsor	BeOne Medicines
Conditions	Advanced Unresectable Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Advanced Gastroesophageal Adenocarcinoma
Enrollment	30 participants
Start Date	2026-04-30
Primary Completion	2031-12-31 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-24