MedTrace Logo

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

NCT06283134 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

  • Colorectal Cancer Metastatic

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.

Sponsors & Collaborators

  • Beijing Bio-Targeting Therapeutics Technology Co., Ltd

    collaborator INDUSTRY

  • China Medical University, China

    lead OTHER

Principal Investigators

  • Zhenning Wang, MD · The First Affiliated Hospital of China Medical Univeristy

  • Funan Liu, MD · The First Affiliated Hospital of China Medical Univeristy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-12-01
Completion
2028-12-01

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06283134 on ClinicalTrials.gov