IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer (NCT07025889) | Clinical Trial Compass
RecruitingPhase 1/2
IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer
China55 participantsStarted 2025-06-02
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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).
What they're measuring
1
Objective response rate (ORR)
Timeframe: up to 2 years
Trial details
NCT IDNCT07025889
SponsorRuijin Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-06
Contact for this trial
Ruijin Hospital, Shanghai Jiao Tong University School of Medic