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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10\^6 TCID50/mL.
Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10\^7 TCID50/mL.
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Safety and tolerability (CTCAE version 4.0).
Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
Time frame: up to Week 16
Overall tumor response (modified World Health Organization response criteria)
Overall tumor response will be evaluated by modified World Health Organization (mWHO) response criteria in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).
Time frame: at Week 12
Levels of antibody to HSV-1
Anti-HSV-1 antibodies will be assessed in serum.
Time frame: up to Week 12
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