IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

NCT ID: NCT07025889

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-02
• Study Completion Date: 2028-06-30

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm

IBI343 Combined with Sintilimab Plus SOX

Group Type: EXPERIMENTAL

IBI343

Intervention Type: 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.

Sintilimab

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

S-1

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Sintilimab

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

S-1

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruijin Hospital, Shanghai Jiao Tong University School of Medic

Role: CONTACT

sm11998@rjh.com.cn

021-64370045

Facility Contacts

Shanghai Jiao Tong University School of Medicine

Role: primary

sm11998@rjh.com.cn

021-64370045

Other Identifiers

Dragon15

Identifier Type: -

Identifier Source: org_study_id