Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Operation Strategy Adjustment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer with Hepatic Metastases | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KN046 （PD-L1/CTLA4 BsAb） | Drug | — | UNRESOLVED |
| TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TATE and KN046
- 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.
- interventionNames
- Drug: KN046 （PD-L1/CTLA4 BsAb）
- Procedure: TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization
Primary outcomes (2)
- measure
- ORR
- timeFrame
- 24 months
- description
- Objective Response Rate (assessed by mRECIST/RECIST)
- measure
- OS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available