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

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a new antibody-drug (IBI343) with an immunotherapy drug (sintilimab) and chemotherapy as a first-line treatment in patients with advanced stomach cancer or cancer at the junction of the stomach and esophagus. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (a specific cancer type), confirmed by biopsy - Your tumor tests positive for a protein called CLDN18.2 - You have not received any prior systemic therapy for this cancer - You are in good health (ECOG 0–1) **You may NOT be eligible if...** - Your tumor tests positive for HER2 (a different protein) - You are currently participating in another interventional clinical study - You have previously received topoisomerase inhibitor-based antibody-drug therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.