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ENROLLING BY INVITATION
NCT06215846
PHASE1

A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors

Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd

View on ClinicalTrials.gov

Summary

This is a Phase 1 open-label study to evaluate the safety, tolerability, and pharmacokinetics of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) at dose of 5×10∧9VP、5×10∧10VP、5×10∧11VP in Patients With Malignant Solid Tumors. Subjects will be treated with a single dose of BioTTT001 Injection after the screening period.

Official title: Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetics of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Patients With Malignant Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-05-07

Completion Date

2026-06-28

Last Updated

2025-11-26

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

BioTTT001 injection

BioTTT001 is administered as a single Intratumoral injection. The dose groups to be infusion were 5×10\^9 VP, 5×10\^10 VP and 5×10\^11 VP based on the 3+3 dose escalation principle.

Locations (1)

The First Affiliated Hospital of China Medical Univeristy

Shenyang, Liaoning, China