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IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllRuijin Hospital
NCT07025889 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a Single-arm, Open-label, Phase 1b/2 Study of IBI343 Combined with Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

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📋 Eligibility rules (as published)
Inclusion Criteria: * 1\. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures. 2\. Age was 18-75 years at the time of signing the ICF, and gender was unlimited. 3\. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC). 4\. No received systemic therapy. 5. Has histopathologically confirmed CLDN18.2-positive disease. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Exclusion Criteria: * 1\. Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease. 2\. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study. 3\. Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).
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What it tests

  • IBI343
  • Sintilimab
  • Oxaliplatin
  • S-1
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Where

1 site
Shanghai Jiao Tong University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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