TATE and KN046 in MCRC

NCT ID: NCT06834399

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2025-01-09

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.

Conditions

Colorectal Cancer with Hepatic Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TATE and KN046

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.

Group Type: EXPERIMENTAL

KN046 （PD-L1/CTLA4 BsAb）

Intervention Type: DRUG

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.

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Zhejiang Raygene Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

RG-KN-001

Identifier Type: -

Identifier Source: org_study_id