NCT07264569

Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001

Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001 in the Treatment of Patients With Recurrent/Progressive Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase Ib/II clinical study on evaluating the safety, tolerance, biodistribution characteristics and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTT001) in the treatment of meningeal metastasis in recurrent/progressive non-small cell lung cancer

Detailed description

This study is a single-arm, open-label, dose-escalation and dose-expansion phase Ib/II clinical trial aimed at evaluating the safety, tolerability, biological distribution characteristics, and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) in patients with recurrent/progressive non-small cell lung cancer with meningeal metastases. The study is divided into two phases: the phase Ib dose-escalation .The dose escalation phase establishes three dosage groups, namely 1.0×10\^9 VP, 5.0×10\^9 VP, and 1.0×10\^10 VP and the phase II dose-expansion.

Conditions

• Meningeal Metastasis

Interventions

Type	Name	Description
BIOLOGICAL	BioTTT001 injection	BioTTT001 is administered as a Intrathecal injection using an Ommaya reservoir.The dosage administered to the subjects is determined based on the group they belong to. This study establishes three dosage groups: 1.0×10\^9 VP, 5.0×10\^9 VP, and 1.0×10\^10 VP.

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: China