NCT06455254

Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM

A Single-arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Candonilimab（AK104） Combined With Regorafenib For the Third-line Treatment of MSS Colorectal Liver Metastasis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Jin-hong Chen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. Candonilimab (AK104) is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.

Detailed description

This is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. The purpose of the study is to observe and evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib in patients with CRLM who had failed the previous second-line standard regimen, and to explore biomarkers related to efficacy.

Conditions

• CRC

Interventions

Type	Name	Description
DRUG	Candonilimab (AK104)	Cadonilimab (AK104): 6mg/kg, i.v. q2w.
DRUG	Regorafenib	Regorafenib: 80 mg p.o. qd for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off).

Timeline

• Start date: 2024-07-11
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2024-06-12
• Last updated: 2024-07-30

Locations

3 sites across 1 country: China