Evaluate Efficacy, Immunological Response of Intratumoral/Intralesional Oncolytic Virus (OBP-301) in Metastatic Melanoma

Exclusion Criteria

• •1. Patients who have had administration of chemotherapy, target therapy, and/or immunotherapy within the last 4 weeks before the first OBP-301 administration.
• •2. Patients who have received other investigational medication within the last 4 weeks or a period of its 5 half-lives (whichever is shorter) before the first OBP-301 administration.
• •3. Patients who have had radiotherapy within the last 4 weeks before the first OBP-301 administration.
• •4. Effects of any other prior therapies not reverted to ≤ Grade 1 (or ≤ Grade 2 for alopecia and peripheral neuropathy).
• •5. Patients who have any liver metastases or visceral metastasis of ≥ 3 cm, plus evidence of progression meeting irRC 1.0 within 1 month before the first OBP-301 administration.
• •6. Patients with clinically active brain metastases. However, patients with previously currently stable brain metastases on medication (i.e., steroids and/or anti-seizure medications) may be enrolled after consultation with the Medical Monitor.
• •7. Patients known to have acute or chronic active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
• •8. Patients diagnosed with additional malignancy within 3 years before the first OBP-301 administration with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
• •9. Patients requiring chronic systemic immunosuppressive medication including pharmacologic dose of glucocorticoids or cyclosporine should be evaluated by the Medical Monitor for enrollment eligibility.
• •10. Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/psychological incompetence, whereby in the opinion of the Investigator the patient is assessed as being unable to provide information, consent, or comply with the study requirements and procedures.
• •11. Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 3 months (90 days) after the last OBP-301 administration. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each visit before administration of OPB-301. A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months.