NCT06215846

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

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

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a single arm, open label, single center dose escalation trial. Three study drug dosage groups are pre-set, namely 5 × 10∧9VP、5 × 10∧10VP、 5 × 10∧11VP. According to the principle of dose escalation from low to high, the "3+3" dose escalation method is adopted. In theory, in order to protect the safety of the subjects, during the DLT observation phase of the same dose group, the first subject in each dose group can only be enrolled in the second subject after at least 2 weeks after administration. The DLT observation period for each subject is 28 days after the first administration, and the last subject in each dose group can only enter the next dose escalation after completing the DLT observation period. At least 3 subjects are enrolled in each dose group, and each subject only receives one corresponding dose.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-07
• Primary completion: 2026-05-30
• Completion: 2026-06-28
• First posted: 2024-01-22
• Last updated: 2025-11-26

Locations

1 site across 1 country: China