TATE and KN046 in MCRC

Phase 2TerminatedNCT06834399

Zhejiang Raygene Pharmaceuticals Co., Ltd42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer with Hepatic Metastases

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：Intra-arterial Administration of Tirapazamine followed by Transarterial EmbolizationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

ORR

Objective Response Rate (assessed by mRECIST/RECIST)

Time frame: 24 months

Overall Survival

Time frame: 24 months

Secondary Outcomes

DCR

Disease control rate

Time frame: 24 months

PFS

Progression-free survival

Time frame: 24 months

survival rates

6-month, 1-year, and 2-year survival rates

Time frame: 24 months

Data from ClinicalTrials.gov

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