TATE and KN046 in MCRC

Phase IIA Clinical Trial of Intra-arterial Administration of Tirapazamine Followed by Transarterial Embolization （TATE）and KN046 for the Treatment of Advanced Colorectal Cancer with Liver Metastasis (MSS/pMMR)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06834399

Enrollment

Registered

2025-02-19

Start date

2023-04-27

Completion date

2025-01-09

Last updated

2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer with Hepatic Metastases

Keywords

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

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.

Interventions

DRUGKN046 （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.

PROCEDURETATE：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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
ORR	24 months	Objective Response Rate (assessed by mRECIST/RECIST)
OS	24 months	Overall Survival

Secondary

Measure	Time frame	Description
DCR	24 months	Disease control rate
PFS	24 months	Progression-free survival
survival rates	24 months	6-month, 1-year, and 2-year survival rates

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026