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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Bioresearch Partners Holding Hialeah Hospital
RECRUITING
Hialeah
Contact Information
Primary
Study Director
clinicaltrials@beonemed.com
1-877-828-5568
Time Frame
Start Date: 2026-04-30
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 30
Treatments
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.
Experimental: Esophageal Squamous Cell Carcinoma (ESCC)
Participants will receive tislelizumab 150 mg Q2W and FOLFOX chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: BeOne Medicines

This content was sourced from clinicaltrials.gov

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