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NOT YET RECRUITING
NCT06283134
PHASE1

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

Sponsor: China Medical University, China

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03

Completion Date

2028-12-01

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

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.