NCT07025889RecruitingPhase 1/2
IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer
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 (Dragon15)
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 5 Jun 2025
- Start date
- 2 Jun 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Ruijin Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07025889
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 55
- From 2 Jun 2025 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.