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Looking for participantsPhase3

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

Sponsor: BeOne Medicines

NCT ID: NCT07043400

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Subcutaneous Tislelizumab (drug), Intravenous Tislelizumab (drug), Cisplatin (drug), Leucovorin (drug)
How long the study runs
Study runs about 32 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
351
Started
2025-08-27
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic gastric adenocarcinoma
  • • Phase3 - 351 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with metastatic gastric adenocarcinoma

Where?

  • • Cambridge - Cambridge University Hospitals Nhs Foundation Trust
  • • Dundee - Ninewells Hospital and Medical School
  • • Metropolitan Borough of Wirral - Clatterbridge Cancer Centre

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Metastatic Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2with positive

What the study is looking for

  • ✓confirmed by a biopsy, that has grown locally unresectable or that has spread gastric/ gastroesophageal junction (GEJ)...
  • ✓No previous treatment that goes through your whole body for that has grown locally unresectable or that has spread gastric/GEJ cancer.
  • ✓At least 1 measurable or nonmeasurable lesion per (standard scan measurements) as determined by investigator assessment.
  • ✓Must be able to provide tumor tissues for test result assessment.
  • ✓activity scale (ECOG) Performance Status score ≤ 1.

Who cannot take part

  • ✗Squamous cell or undifferentiated or other histological type gastric cancer (GC)
  • ✗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)...
  • ✗NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
See the full criteria
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.

Where Is This Study? (3 UK sites)

Cambridge University Hospitals Nhs Foundation Trust

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Ninewells Hospital and Medical School

Dundee DD1 9SY, United Kingdom

Recruiting

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

How to Get in Touch

BeOne Medicines

Sponsor contact

CONTACT

1-877-828-5568 clinicaltrials@beonemed.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09