Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. This was a phase II study of cadonilimab in combination with bevacizumab and FOLFOXIRI as first line therapy for metastatic microsatellite stable (MSS) colorectal cancer. The goal of this clinical trial is to evaluated the efficacy and safety.
Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. This was a phase II study of cadonilimab in combination with bevacizumab and FOLFOXIRI as first line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The goal of this clinical trial is to evaluated the efficacy and safety. Cadonilimab (6mg/kg, iv, Q2W, Day1)+irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1; oxaliplatin 85 mg/m² iv continue for 2 hours, D1; leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours, D1; 5-FU 2400 mg/m² cont. inf. 48h; repeat every 2 weeks (Q2W) + bevacizumab (5mg/kg,d 1)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Cadonilimab (6mg/kg, iv, Q2W, Day1)
irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1
oxaliplatin 85 mg/m² iv continue for 2 hours,
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGOverall Response Rate (ORR)
RECIST 1.1
Time frame: Up to two years
Progression free survival (PFS)
RECIST 1.1
Time frame: Up to two years
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leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours
5-FU 2400 mg/m² cont. inf. 46h