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IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

NCT07025889 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-06-18

No results posted yet for this study

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

Interventions

DRUG

IBI343

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.

DRUG

Sintilimab

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

DRUG

Oxaliplatin

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

DRUG

S-1

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

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Min Shi, MD · Ruijin Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2026-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07025889 on ClinicalTrials.gov