To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followed by electroporation.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
IL-2-encoding plasmid formulated in phosphate-buffered saline at 0.5 mg/mL, 1.5 mg/mL, and 5.0 mg/mL (VCL-IM01) intratumorally injected and followed by electroporation with Inovio MedPulser® 1.0 cm array with needles up to 3 cm long (one 6-pulse cycle per tumor).
Location #2
Mobile, Alabama, United States
Location #3
Denver, Colorado, United States
Location #1
Chicago, Illinois, United States
Location #4
Montclair, New Jersey, United States
Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma
Time frame: After all subjects have been enrolled
Overall response rate, duration of response, treated tumor response rate, assessment of injected tumor(s) for induration, inflammation, and erythema, and serum levels of IL-2.
Time frame: After all subjects have been enrolled
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