IBI343 plus sintilimab and chemotherapy for CLDN18.2-positive gastric or gastroesophageal junction cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label phase 1b/2 trial combines IBI343 with the PD‑1 inhibitor sintilimab and chemotherapy (oxaliplatin plus S‑1) in previously untreated, CLDN18.2-positive, HER2-negative advanced G/GEJ adenocarcinoma. A 3+3 dose-escalation stage identifies the recommended phase II dose, followed by dose-expansion cohorts including 25 patients in a general CLDN18.2-positive cohort and 15 patients with signet-ring cell histology. The study’s primary aims are to characterize safety and tolerability and to generate preliminary efficacy data including response rates and progression-free survival. Key eligibility includes age 18–75, ECOG 0–1, no prior systemic therapy, and confirmed CLDN18.2-positive, HER2-negative disease.

Why it matters

Who can join: the full rules

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).

Where it's running

• Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Min Shi, MD — Ruijin Hospital
• Study coordinator: Ruijin Hospital, Shanghai Jiao Tong University School of Medic
• Email: sm11998@rjh.com.cn
• Phone: 021-64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.