A Phase 1, Open-Label, Dose Escalation and Expansion Study of ASP1012, an Oncolytic Virus, in Participants with Locally Advanced or Metastatic Solid Tumors

• Western Reserve vaccinia virus that expresses CCR2 and leptin-IL2.

In this study, the sponsor and investigators want to learn:

• How much of the study agent can be given with an acceptable level of side effects
• The effects of the study agent (good and bad)
• How much of the study agent is absorbed into the blood and how fast it is removed
• How the study agent is acting on your body
• If research tests can be used in the future to predict who will benefit from ASP1012

This study has three parts, Part 1 dose escalation, Part 2 dose expansion (treated and untreated melanoma patients and previously treated solid tumors) and Part 3 dose expansion (gastric cancer, colorectal cancer, ovarian cancer and other solid tumor type patients). Part 2 and Part 3 will not start until after Part 1 is completed. You can only participate in one part of the study, not all.

You will be in the study for roughly 18 months (or about 1 year and 6 months) from the time you consent to participate until the last visit. There will be 3 different study periods.

This includes about 4 weeks for screening, three 21-day cycles (weekly treatment for a total of 9 weeks) of the initial treatment, and follow-up 30 days after your last investigational drug of ASP1012 and continued follow-up every 6th and 12th week, thereafter. However, the actual length of time you will be in the study will vary depending on how you respond to the treatment.

During this study, you will receive ASP1012 directly into your veins through an intravenous (IV) infusion, once a week. You will have to go to the clinic or hospital to receive the IV infusions. You will be required to stay at the hospital after you receive the investigational drug infusion for 12 hours for the first 3 doses and changing to 4 hours with the fourth dose if you do not have any serious side effects.