TATE and KN046 in MCRC

Phase 2

Terminated

• Conditions: Colorectal Cancer with Hepatic Metastases
• Interventions: Drug: KN046 （PD-L1/CTLA4 BsAb）; Procedure: TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization

• Registration Number: NCT06834399
• Lead Sponsor: Zhejiang Raygene Pharmaceuticals Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-27
• Primary Completion: 2024-12-17
• Study Completion: 2025-01-09
• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TATE and KN046	KN046 （PD-L1/CTLA4 BsAb）	On Day 1, patients will receive KN046 at a dose of 5 mg/kg. On Day 8 (+/-1), patients will receive TATE (Tirapazamine 35 mg). Each treatment cycle is 21 days. Patients will receive two cycles of treatment. After necrosis of liver tumors, whether to continue TATE treatment in the third cycle and beyond will be decided by the study physician based on the extent of tumor necrosis.
TATE and KN046	TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization	On Day 1, patients will receive KN046 at a dose of 5 mg/kg. On Day 8 (+/-1), patients will receive TATE (Tirapazamine 35 mg). Each treatment cycle is 21 days. Patients will receive two cycles of treatment. After necrosis of liver tumors, whether to continue TATE treatment in the third cycle and beyond will be decided by the study physician based on the extent of tumor necrosis.

Primary Outcome Measures

Name	Time	Method
ORR	24 months	Objective Response Rate (assessed by mRECIST/RECIST)
OS	24 months	Overall Survival

Secondary Outcome Measures

Name	Time	Method
DCR	24 months	Disease control rate
PFS	24 months	Progression-free survival
survival rates	24 months	6-month, 1-year, and 2-year survival rates

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China