NCT02428036

A Study of TBI-1401(HF10) in Patients With Solid Tumors With Superficial Lesions

A Phase I Study of Repeated Intratumoral Administration of TBI-1401(HF10), a Replication Competent HSV-1 Oncolytic Virus, in Patients With Solid Tumors With Superficial Lesions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Takara Bio Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether TBI-1401(HF10), a spontaneously attenuated mutant of Herpes Simplex Virus Type 1 (HSV-1), is safe and tolerable in the treatment of solid tumors with superficial lesions.

Detailed description

This is an open label, non-randomized, dose escalation Phase I study evaluating the repeated intratumoral administrations of the TBI-1401(HF10), a spontaneously attenuated mutant of HSV-1, in patients with solid tumors with superficial lesions (e.g., malignant melanoma and squamous cell carcinoma of the skin). The study will evaluate the safety and tolerability of repeated intratumoral administrations of TBI-1401(HF10) at dose levels of 1 x 10\^6 TCID50/dose (cohort 1) and 1 x 10\^7 TCID50/dose (cohort 2) in Japanese patients. Three patients will be enrolled in each cohort. Patients in the each cohort will receive a total of four intratumoral administrations in the same lesion.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	TBI-1401(HF10)	Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10\^6 TCID50/mL.
BIOLOGICAL	TBI-1401(HF10)	Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10\^7 TCID50/mL.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-10-01
• Completion: 2017-06-01
• First posted: 2015-04-28
• Last updated: 2017-07-02

Locations

1 site across 1 country: Japan