IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

Phase 1

Recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: IBI343; Drug: Sintilimab; Drug: Oxaliplatin; Drug: S-1

• Registration Number: NCT07025889
• Lead Sponsor: Ruijin Hospital

Brief 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

Detailed Description

This trial is a phase Ib/II study to evaluate the safety, tolerability and efficacy of IBI343 in combination with sintilimab and chemotherapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. In dose-escalation stage, patients with CLDN 18.2-positive, HER2-negative were treated with IBI 343, sintilimab, and chemotherapy (oxaliplatin, S-1) as first-line therapy, which followed a 3+3 design. The dose expansion stage aimed to further investigate the safety and preliminary efficacy of recommended phase II dose (RP2D), including Cohort 1 and Cohort 2. In Cohort 1, 25 patients with CLDN18.2-positive, HER2-negative advanced G/GEJ adenocarcinoma will be enrolled. In Cohort 2, 15 patients with CLDN18.2-positive, HER2-negative gastric signet-ring cell carcinoma will be enrolled.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-02
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Primary Completion: 2026-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	IBI343	IBI343 Combined with Sintilimab Plus SOX
Experimental arm	Sintilimab	IBI343 Combined with Sintilimab Plus SOX
Experimental arm	Oxaliplatin	IBI343 Combined with Sintilimab Plus SOX
Experimental arm	S-1	IBI343 Combined with Sintilimab Plus SOX

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	up to 2 years	ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) as assessed by the IRRC per RECIST v1.1 criteria.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	up to 2 years	Overall survival (OS) is defined as the time from enrollment to death from any cause.
Progression-free survival (PFS)	up to 2 years	Progression-free survival (PFS) is defined as the time from enrollemnt to disease progression or death from any cause.
Disease control rate (DCR)	up to 2 years	DCR is defined as the proportion of subjects in the analysis population who achieve disease control (CR, PR, or SD) as determined by the IRRC per RECIST v1.1 criteria.
Treatment-related adverse event (TRAE)	up to 2 years	Safety evaluation, such as hematotoxicity, hepatotoxicity, and renal function lab test, done continuously during treatment and the level of serum creatinine will be evaluated by using CTCAE 5.0 during study.

Trial Locations

Locations (1)

Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China