TATE and KN046 in MCRC

Zhejiang Raygene Pharmaceuticals Co., Ltd

Status and phase: Terminated; Phase 2

Conditions: Colorectal Cancer with Hepatic Metastases

Treatments: Procedure: TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization; Drug: KN046 （PD-L1/CTLA4 BsAb）

Study type: Interventional

Funder types: Industry

Identifiers

NCT06834399

RG-KN-001

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

TATE and KN046

Experimental group

Description:

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.

Treatment:

Drug: KN046 （PD-L1/CTLA4 BsAb）

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