A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors
Trial Parameters
Brief Summary
AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration. The purpose of this study is to find out if AdAPT-001 is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor.
Eligibility Criteria
Inclusion Criteria: 1. Subject is capable of understanding the purpose and risks of the study and has provided written Informed Consent. 2. Subject is male or female, aged at least 18 years. 3. Subject has a histologically or cytologically confirmed diagnosis of an advanced malignant solid tumor(s) who have received all conventional therapies considered appropriate by Investigator and have a tumor that is easily accessible and/or palpable for treatment. Ultrasound guidance may be used to aid administration. 4. Subject's Eastern Cooperative Group (ECOG) performance status is 0-1 at Screening. 5. Subject has acceptable liver function at Screening, as evidenced by: 1. Bilirubin \< 1.5 x ULN (upper limit of normal) 2. AST (SGOT) and ALT (SGPT) \< 3.0 x ULN (upper limit of normal) 3. Alkaline Phosphatase \< 2.5 x ULN (upper limit of normal) 6. Subject has a Serum Creatinine \< 1.5 x ULN (upper limit of normal) 7. Subject has acceptable hematologic status at Screening, as evidenced by: 1. Ab