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

StatusNot Yet Recruiting
PhasePhase 1
Started2026-03
View on ClinicalTrials.gov ↗

Amendment history

2026-01-04
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v2
Completion date2027-12-01→2028-12-01
Start date2024-04-02→2026-03
Enrollment target40→60
Eligibility criteriarevised
[...] tigator to be unsuitable for standard therapy; At least one assessablemeasurable lesion according to the Response Evaluation Criteria in Sol [...]
Secondary endpointsdetails revised at 6 of 7 entries
Study description-90 characters
[...] ioTTT001 monotherapy (hepatic artery infusion, administered every 2 weeks,on D1 and D15D8 for a total of two doses) after enrollment. If the subject [...] of BioTTT001 in combination with toripalimab and regorafenib 2 weeks after the first dose of BioTTT001 ( toripalimab 80mg160mg iv. D1 and D15 , BioTTT001 5×10^79 viral particle (VP)/5×10^8 VP/5×10^9 VP/1×10^1011 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 pha [...] [...]
2024-02-27
Study Identification, Study Status v1
Study title-22 characters
A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Liver Metastases From Colorectal Cancer
2024-02-22
Original filing
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.
Trial Details
NCT Number NCT06283134
Lead Sponsor China Medical University, China
Collaborators: Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Conditions Colorectal Cancer Metastatic
Enrollment 60 participants
Start Date 2026-03
Primary Completion 2027-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-07