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Clinical Trial Summary

This is a phase I, open-label clinical study of BioTTT001 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer.


Clinical Trial Description

This study includes a dose escalation phase and a dose expansion phase. The dose escalation phase will adopt a 3+3 design. Subjects were first treated with BioTTT001 monotherapy (hepatic artery infusion, administered every 2 weeks, D1 and D15 for a total of two doses) after enrollment. If the subject does not develop dose-limiting toxicity (DLT) in the monotherapy stage and is judged to be safe and tolerable by the investigator, the subject will enter the treatment phase of BioTTT001 in combination with toripalimab and regorafenib( toripalimab 80mg iv. D1 and D15 , BioTTT001 5×10^7 viral particle (VP)/5×10^8 VP/5×10^9 VP/1×10^10 VP hepatic arterial infusion (HAI.) D2 and D16 , regorafenib 80 mg Po. D1-D21; 4 weeks per cycle), and the dose of BioTTT001 will be determined according to the safety observation results in the monotherapy phase. In the dose expansion phase, different dose groups can be expanded, and the total number of enrolled subjects is expected to be 30 for further safety, tolerability, pharmacokinetics and preliminary efficacy evaluation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06283134
Study type Interventional
Source China Medical University, China
Contact Shuhui Song, bachelor
Phone 15004240769
Email 593900927@qq.com
Status Not yet recruiting
Phase Phase 1
Start date April 2, 2024
Completion date December 1, 2027

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