A Phase 1, Multi-Center, Open-Label, Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
Eligible subjects will receive intratumoral injections of VCL-IM01 followed by
electroporation of the injected tumor(s).
Subjects will be enrolled to receive one course of treatment. A course of treatment is two
cycles, each cycle consisting of four weekly injection/electroporation administrations
followed by an observation period of two weeks.
Subjects' tumors will be evaluated at Screening, at the end of Cycle 2, and at six months
(Week 26) from the initial drug administration.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma
After all subjects have been enrolled
Dmitri D. Kharkevitch, MD, PhD
United States: Food and Drug Administration
|Location #2||Mobile, Alabama 36606|
|Location #3||Denver, Colorado 80045|
|Location #1||Chicago, Illinois 60068|
|Location #4||Montclair, New Jersey 07042|