TATE and KN046 in MCRC

NCT06834399 | Terminated Phase 2

• 1 other identifier: RG-KN-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Colorectal Cancer; Liver Metastasis; Tirapazamine; KN046 (PD-L1/CTLA-4 Bispecific Antibody)

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective Response Rate (assessed by mRECIST/RECIST)

  24 months

• OS

  Overall Survival

  24 months

Secondary Outcomes (3)

• DCR

  24 months

• PFS

  24 months

• survival rates

  24 months

Study Arms (1)

TATE and KN046

EXPERIMENTAL

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.

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

Interventions

KN046 （PD-L1/CTLA4 BsAb） 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 and KN046

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

TATE and KN046

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver metastatic MSS/pMMR-mCRC;
• mCRC progressed on at least two lines of standard chemotherapy;
• Measurable disease;
• ECOG 0-1;
• Adequate organ function

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Raygene Pharmaceuticals Co., Ltd: lead
• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: April 27, 2023
• Primary Completion: December 17, 2024
• Study Completion: January 9, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)