IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Gastric Cancer

In brief

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

Key facts

Study ID

NCT07025889

Run by

Ruijin Hospital

People needed

55

Starts

2025-06-02

Expected to finish

2028-06-01

Last updated by the study team

2025-06-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures.
• Age was 18-75 years at the time of signing the ICF, and gender was unlimited.
• Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
• 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.

You may not qualify if…

• 1. Has HER2-positive (defined as immunohistochemistry [IHC] 3+, or IHC 2+ and positive by in situ hybridization) disease.
• Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
• Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).

Where it is running

• Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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