Business Operation Strategy Adjustment

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.

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.

International meeting report or medical Journal publication