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IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer
Sponsor: Ruijin Hospital
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
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2025-06-02
Completion Date
2028-06
Last Updated
2025-06-18
Healthy Volunteers
No
Conditions
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.
Sintilimab
Subjects will receive sintilimab 200mg IV D1 Q3W in 3-week cycles.
Oxaliplatin
Subjects will receive oxaliplatin 130mg/m2 IV D1 Q3W in 3-week cycles.
S-1
Subjects will receive S-1 40-60mg BID PO D1-14 Q3W in 3-week cycles.
Locations (1)
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China