RecruitingPhase 1Phase 2NCT07025889

IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

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 (Dragon15)

Sponsor

Ruijin Hospital

Enrollment

55 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

\. 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.

Exclusion Criteria3

\. 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).

Interventions

DRUGIBI343

Subjects in the phase 1b stage will receive IBI343 3/4.5/6mg/kg intravenous infusion (IV) D1 Q3W in 3-week cycles. Subjects in the phase 2 stage will receive IBI343 RP2D intravenous IV D1 Q3W in 3-week cycles.

DRUGSintilimab

Subjects will receive sintilimab 200mg IV D1 Q3W in 3-week cycles.

DRUGOxaliplatin

Subjects will receive oxaliplatin 130mg/m2 IV D1 Q3W in 3-week cycles.

DRUGS-1

Subjects will receive S-1 40-60mg BID PO D1-14 Q3W in 3-week cycles.