NCT06283134

A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer

A Clinical Study to Evaluate the Safety and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Combination With Toripalimab and Regorafenib in Patients With Liver Metastases From Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 on D1 and D8 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 2 weeks after the first dose of BioTTT001 ( toripalimab 160mg iv. D1 and D15 , BioTTT001 5×10\^9 viral particle (VP)/5×10\^10 VP/1×10\^11 VP hepatic arterial infusion (HAI.) D2 and D16 , regorafenib 80 mg Po. D1-D21; 4 weeks per cycle). In the dose expansion phase, different dose groups can be expanded, and the total number of enrolled subjects is expected to be 23\~48 for further safety, tolerability, pharmacokinetics and preliminary efficacy evaluation.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	BioTTT001 hepatic artery infusion	BioTTT001 monotherapy period: BioTTT001 5×10\^9 VP/5×10\^10VP/1×10\^11 VP hepatic artery infusion, administered on D1 and D8, for a total of two doses after enrollment. BioTTT001 in combination with toripalimab and regorafenib period: BioTTT001 5×10\^9 VP/5×10\^10VP/1×10\^11 VP hepatic artery infusion, D2 and D16, 4 weeks per cycle.
DRUG	toripalimab	BioTTT001 in combination with toripalimab and regorafenib period: toripalimab 160mg intravenous D1 and D15, 4 weeks per cycle.
DRUG	regorafenib	BioTTT001 in combination with toripalimab and regorafenib period: regorafenib 80 mg oral administration, D1-D21, 4 weeks per cycle.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-02-28
• Last updated: 2026-01-07