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NCT Number: NCT07043400

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

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.

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Key information

Conditions

Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Aleman, CABA, Argentina

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About this study

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma.
  • No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
  • At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.
  • Must be able to provide tumor tissues for biomarker assessment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.
  • Adequate organ function.
  • 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.
  • 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.

Exclusion criteria

  • Squamous cell or undifferentiated or other histological type gastric cancer (GC)
  • 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 randomization.
  • Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).
  • Active autoimmune diseases or history of autoimmune diseases that may relapse.
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization

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

Treatment and study plan

Subcutaneous Tislelizumab

Drug

Administered by subcutaneous injection

Other names: BGB-A317

Intravenous Tislelizumab

Drug

Administered by intravenous infusion

Other names: BGB-A317, TEVIMBRA®

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

Primary outcomes

  1. Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab

    Time frame: 85 Days

  2. Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab

    Time frame: 21 Days

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 2 years

    ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  2. Progression-Free Survival (PFS)

    Time frame: Up to 2 years

    PFS is defined as the time from randomization date until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1

  3. Duration of Response (DOR)

    Time frame: Up to 2 years

    DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as assessed by the investigator using RECIST v1.1

  4. Disease Control Rate (DCR)

    Time frame: Up to 2 years

    DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1

  5. Overall Survival (OS)

    Time frame: Up to 2 years

    OS is defined as the time from first study drug administration to the date of death due to any cause

  6. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 2 years

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.

  7. Model-predicted Serum Ctrough at Cycle 1

    Time frame: 21 Days

  8. Observed Serum Ctrough at Cycle 1

    Time frame: 21 Days

  9. Observed Area Under the Concentration-time Curve at Steady-state (AUC) at Cycle 1

    Time frame: 21 Days

  10. Model-predicted Area Under the Concentration-time Curve at Steady-state (AUCss)

    Time frame: 85 Days

  11. Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab after SC or IV Administration

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

BeOne Medicines

CONTACT

[email protected]

1-877-828-5568

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 29, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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