RecruitingPhase 2NCT05985109

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


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

98 participants

Start Date

Oct 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of KN046 (a dual-target immunotherapy that blocks both PD-L1 and CTLA-4) and regorafenib (a targeted therapy drug) in people with metastatic colorectal cancer that does not respond to standard immunotherapy (MSS/pMMR subtype) and has progressed after standard chemotherapy. **You may be eligible if:** - You are 18 or older with confirmed metastatic colorectal cancer - Your cancer has progressed after fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy - You have at least one measurable tumor on imaging - Your overall health is good (ECOG score 0–1) - Your blood counts and organ function meet minimum standards **You may NOT be eligible if:** - Your cancer is the MSI-high/dMMR subtype (which typically responds to standard immunotherapy) - You have active brain metastases or autoimmune disease - You have uncontrolled bleeding, serious infections, or severe organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKN046

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.

DRUGregorafenib

Regorafenib is a multi-target tyrosine kinase inhibitors and is one of the standard third-line therapy in mCRC


Locations(1)

Beijing Cancer Hospital

Beijing, China

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NCT05985109


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