NCT06834399

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Zhejiang Raygene Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer with Hepatic Metastases

Interventions

Type	Name	Description
DRUG	KN046 （PD-L1/CTLA4 BsAb）	KN046 is administered every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, study end, or other discontinuation criteria are met.
PROCEDURE	TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization	TATE treatment is given every 21 days. Patients receive two initial cycles. Whether to continue TATE treatment from the third cycle onward is decided by the investigator based on tumor necrosis. If a patient experiences intrahepatic tumor progression (recurrence or new tumors) during follow-up after the third cycle and still meets the treatment criteria, additional TATE treatment may be given.

Timeline

• Start date: 2023-04-27
• Primary completion: 2024-12-17
• Completion: 2025-01-09
• First posted: 2025-02-19
• Last updated: 2025-02-19

Locations

1 site across 1 country: China