Recruiting
Phase 2

Tislelizumab

Sponsor:

BeOne Medicines

Code:

NCT07554521

Conditions

Advanced Unresectable Gastric Adenocarcinoma

Esophageal Squamous Cell Carcinoma

Advanced Gastroesophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tislelizumab

Capecitabine

5-fluorouracil (5-FU)

Oxaliplatin

Leucovorin

Study Details

Brief 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.

Conditions

Advanced Unresectable Gastric Adenocarcinoma

Esophageal Squamous Cell Carcinoma

Advanced Gastroesophageal Adenocarcinoma

Study ID

NCT07554521

Start date

Apr 30, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Tislelizumab

Administered by intravenous infusion

Capecitabine

Administered orally

5-fluorouracil (5-FU)

Administered by intravenous infusion

Oxaliplatin

Administered by intravenous infusion

Leucovorin

Administered by intravenous infusion

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 12 months ]

Central Contacts and Locations

Central contacts

Study Director

1-877-828-5568clinicaltrials@beonemed.com

Locations

Helios Clinical Research

Recruiting

Cerritos, California, United States, 90703

Los Angeles Cancer Network

Recruiting

Los Angeles, California, United States, 90017-4803

Brcr Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

Bioresearch Partners Holding Hialeah Hospital

Recruiting

Hialeah, Florida, United States, 33013-3804

Florida Clinical Trials Group Plantation

Recruiting

Plantation, Florida, United States, 33322

Florida Clinical Trials Group Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110-1010

Gabrail Cancer Center Research

Recruiting

Canton, Ohio, United States, 44718-2566

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-24.