A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma

A Phase 1, Multi-Center, Open-Label, Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma

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.

Inclusion Criteria - Key criteria include:

• Confirmed recurrent metastatic melanoma
• Tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment
• Able to carry out normal daily activities and light work without assistance
• Not currently receiving chemotherapy or immunotherapy
• Normal blood chemistries and blood cell counts (elevation of LDH to less than or equal to 1.5 times normal is allowed)
• Able and willing to give informed consent.

Exclusion Criteria - Key criteria include:

• History of brain tumors (resected or stereotactically treated is allowed)
• History of liver tumors
• Subjects whose melanoma can be cured by surgery
• Pregnant
• Subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.