IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

Summary

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

Eligibility

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).

Conditions2

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