TATE and KN046 in MCRC

Phase IIA Clinical Trial of Intra-arterial Administration of Tirapazamine Followed by Transarterial Embolization （TATE）and KN046 for the Treatment of Advanced Colorectal Cancer with Liver Metastasis (MSS/pMMR)

NCT06834399•Zhejiang Raygene Pharmaceuticals Co., Ltd

View on ClinicalTrials.gov

Summary

A single-arm, multicenter, Phase IIA study of Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization (TATE) and KN046 (recombinant humanized anti-PD-L1/CTLA-4 bispecific single-domain antibody Fc fusion protein injection) in patients with liver metastases from colorectal cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Liver metastatic MSS/pMMR-mCRC;
•mCRC progressed on at least two lines of standard chemotherapy;
•Measurable disease;
•ECOG 0-1;
•Adequate organ function

Exclusion Criteria

•Prior organ transplantation;
•Oxygen saturation less than 92% in room air;
•Prior autoimmune disorder;
•Major GI bleeding in the last 2 months;
•Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or immune checkpoint pathways.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

April 27, 2023

Primary Completion Date

December 17, 2024

Completion Date

January 9, 2025

Last Updated

February 19, 2025

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer with Hepatic Metastases

Interventions

KN046 （PD-L1/CTLA4 BsAb）

DRUG

TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization

PROCEDURE