A Phase 2 interventional study of KN046 （PD-L1/CTLA4 BsAb） and TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization in Colorectal Cancer with Hepatic Metastases, sponsored by Zhejiang Raygene Pharmaceuticals Co., Ltd. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Zhejiang Raygene Pharmaceuticals Co., Ltd · Phase 2, Interventional, and Treatment
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 42 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with Zhejiang Raygene Pharmaceuticals Co., Ltd as lead sponsor.
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Exclusion Criteria:
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
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 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.
ORR
Objective Response Rate (assessed by mRECIST/RECIST)
Time frame: 24 months
OS
Overall Survival
Time frame: 24 months
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
Plan to share: No — International meeting report or medical Journal publication
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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