NCT05839470

Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer

A Phase II, Prospective, Multicenter Study of Cadonilimab in Combination With FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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）

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	cadonilimab	Cadonilimab (6mg/kg, iv, Q2W, Day1)
DRUG	irinotecan	irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1
DRUG	Oxaliplatin	oxaliplatin 85 mg/m² iv continue for 2 hours,
DRUG	leucovorin or levoleucovorin	leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours
DRUG	5-FU	5-FU 2400 mg/m² cont. inf. 46h

Timeline

• Start date: 2023-11-19
• Primary completion: 2024-03-01
• Completion: 2025-03-01
• First posted: 2023-05-03
• Last updated: 2023-11-15

Locations

1 site across 1 country: China