Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

July 10, 2024

Primary Completion Date

August 10, 2026

Study Completion Date

December 30, 2027

Conditions
Metastatic HER2 Positive Gastroesophageal Junction Cancer
Interventions
DRUG

cadonilimab

Cohort 1:10 mg/kg, iv, Q3W, D1; Cohort 2/3:6 mg/kg, iv, Q2W, D1

DRUG

Trastuzumab

loading dose 8 mg/kg, iv, Q3W, D1; maintenance dose 6 mg/kg, iv, Q3W, D1

DRUG

XELOX

Oxaliplatin: 130 mg/m\\(\^2\\), IV, D1; Capecitabine: 1000 mg/m\\(\^2\\), oral (PO), twice daily, D1-14.

DRUG

Disitamab Vedotin

1.5、2.0、2.5mg/kg,IV,D1,Q2W

DRUG

mFOLFOX6

Oxaliplatin 85 mg/m\\(\^2\\), IV, d1; Leucovorin (folinic acid) 400 mg/m\\(\^2\\), IV, d1; 5-FU 400 mg/m\\(\^2\\), IV, d1, followed by 2400 mg/m\\(\^2\\), continuous intravenous infusion over 46 hours.

Trial Locations (1)

310022

RECRUITING

Zhejiang Cancer Hospital, Hangzhou

All Listed Sponsors
lead

Zhejiang Cancer Hospital

OTHER