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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
BeOne Medicines
Study ID
NCT07043400
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Gastroesophageal Junction Adenocarcinoma
  • Metastatic Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Subcutaneous Tislelizumab — DRUG
    Administered by subcutaneous injection
  • Intravenous Tislelizumab — DRUG
    Administered by intravenous infusion
  • Cisplatin — DRUG
    Administered by intravenous infusion
  • Leucovorin — DRUG
    Administered by intravenous infusion
  • 5-fluorouracil (5-FU) — DRUG
    Administered by intravenous infusion
  • Oxaliplatin — DRUG
    Administered by intravenous infusion
  • Capecitabine — DRUG
    Administered orally

Study Details

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.

Key Dates

Start date
Aug 27, 2025
Status verified
May 2026
Primary completion
Oct 30, 2027
Completion
Apr 22, 2028

Study Design

Enrollment
351 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Tislelizumab Subcutaneous + Chemotherapy
    Participants will receive tislelizumab 300 mg subcutaneous (SC) injection on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.
  • Active Comparator: Arm B: Tislelizumab Intravenous Infusion + Chemotherapy
    Participants will receive tislelizumab 200 mg intravenous infusion (IV) on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.

Primary Outcome Measure

Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab [ Time Frame: 85 Days ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Ironwood Cancer and Research CentersChandlerArizona85224-5665-
Cancer and Blood Specialty ClinicLos AlamitosCalifornia90720-
UC Health Cancer Care and Hematology Clinic Memorial Hospital CentralColorado SpringsColorado80909-
Bioresearch Partners Holding Hialeah HospitalHialeahFlorida33013-3804-
Orlando Health Ufhealth Cancer CenterOrlandoFlorida32806-2134-
Northwestern UniversityChicagoIllinois60611-
Hope and Healing Cancer ServicesHinsdaleIllinois60521-0509-
University of Kansas Medical Center Research InstituteKansas CityKansas66160-8500-
New England Cancer SpecialistsWestbrookMaine04092-
St Louis Cancer Care, LlpBridgetonMissouri63044-
Nebraska Hematology OncologyLincolnNebraska68506-7548-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-3321-
Hunterdon Hematology OncologyFlemingtonNew Jersey08822-4603-
Summit Medical GroupFlorham ParkNew Jersey07932-1049-
Oregon Oncology SpecialistsSalemOregon97301-
Vanderbilt UniversityNashvilleTennessee37232-
Md Anderson Cancer CenterHoustonTexas77030-3907-
Scott and White Memorial HospitalTempleTexas76508-0001-
Northwest Medical SpecialtiesTacomaWashington98405-

Find similar trials in Chandler, AZ

By research site
Ironwood Cancer and Research Centers· Chandler, AZCancer and Blood Specialty Clinic· Los Alamitos, CAUC Health Cancer Care and Hematology Clinic Memorial Hospital Central· Colorado Springs, COBioresearch Partners Holding Hialeah Hospital· Hialeah, FLOrlando Health Ufhealth Cancer Center· Orlando, FLNorthwestern University· Chicago, IL

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