Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT07025889

IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

Led by Ruijin Hospital · Updated on 2025-06-18

55

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

R

Ruijin Hospital

Lead Sponsor

S

Shanghai Jiao Tong University School of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to sign informed consent and follow study procedures
  • Age 18 to 75 years at the time of consent, any gender
  • Histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of gastric/gastroesophageal junction
  • No prior systemic therapy for the cancer
  • Confirmed Claudin 18.2-positive disease
  • Eastern Cooperative Oncology Group performance status of 0 or 1
Not Eligible

You will not qualify if you...

  • HER2-positive disease defined by specific immunohistochemistry or in situ hybridization criteria
  • Currently participating in another interventional clinical study, except survival follow-up
  • History of treatment with topoisomerase inhibitor-based antibody-drug conjugates

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

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Research Team

R

Ruijin Hospital, Shanghai Jiao Tong University School of Medic

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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