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OncoMatch/Clinical Trials/NCT07025889

IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

Is NCT07025889 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including IBI343 and Sintilimab for gastric cancer.

Phase 1/2RecruitingRuijin HospitalNCT07025889Data as of Jun 2026Location: China

Treatment: IBI343 · Sintilimab · Oxaliplatin · S-1This 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

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Sintilimab

Chemotherapy

Oxaliplatin

Other

IBI343S-1

Cancer type

Gastric Cancer

Biomarker criteria

Required: CLDN18 CLDN18.2-positive

histopathologically confirmed CLDN18.2-positive disease

Required: HER2 (ERBB2) overexpression (IHC 3+, or IHC 2+ and positive by in situ hybridization)

HER2-positive (defined as immunohistochemistry [IHC] 3+, or IHC 2+ and positive by in situ hybridization) disease

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: topoisomerase inhibitor-based antibody-drug conjugate

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07025889 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require CLDN18?

Yes, CLDN18 CLDN18.2-positive is a required biomarker for enrollment.

Does this trial require ERBB2?

Yes, ERBB2 overexpression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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