NCT05985109

KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer

A Phase II Multi-cohort Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib for Metastatic Microsatellite-Stable Colorectal Cancer: a Phase II Multi-cohort Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an interventional Phase II clinical trial aiming to optimize immunotherapy strategies for microsatellite-stable colorectal cancer. We will include three types of metastatic colorectal cancer patients: those without liver metastasis, or carrying BRAF V600E mutation, or unable to tolerate chemotherapy as their initial or second-line treatment. The participants will receive a combination treatment of regorafenib and KN046 which is a PD-L1/CTLA-4 bispecific antibody. Treatment efficacy and safety profile would be evaluated in this study.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	KN046	KN046 is a recombinant humanized PD-L1/CTLA-4 bispecific single-domain antibody that blocks both PD-L1 interaction with PD-1 and CTLA-4 interaction with CD80/CD86.
DRUG	regorafenib	Regorafenib is a multi-target tyrosine kinase inhibitors and is one of the standard third-line therapy in mCRC

Timeline

• Start date: 2023-10-26
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-08-14
• Last updated: 2023-10-26

Locations

1 site across 1 country: China