IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

NCT07025889 | Recruiting Phase 1 DMC

• 1 other identifier: Dragon15
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer

Keywords

Gastric Cancer; IBI 343; Sintilimab

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  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.

  up to 2 years

Secondary Outcomes (4)

• Overall survival (OS)

  up to 2 years

• Progression-free survival (PFS)

  up to 2 years

• Disease control rate (DCR)

  up to 2 years

• Treatment-related adverse event (TRAE)

  up to 2 years

Study Arms (1)

Experimental arm

EXPERIMENTAL

IBI343 Combined with Sintilimab Plus SOX

Drug: IBI343; Drug: Sintilimab; Drug: Oxaliplatin; Drug: S-1

Interventions

IBI343 DRUG

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.

Experimental arm

Sintilimab DRUG

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

Experimental arm

Oxaliplatin DRUG

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

Experimental arm

S-1 DRUG

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

Experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; Oxaliplatin; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Min Shi, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruijin Hospital, Shanghai Jiao Tong University School of Medic

CONTACT

021-64370045; sm11998@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 18, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)