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A compassionate use, expanded access protocol for patients who have exhausted all standard therapy having progressed on chemotherapy and immunotherapy.
Patients will receive intratumoral or subcutaneous injection of an oncolytic virus called PSV (short for Personalized Virus) every other week until the occurrence of immune related RECIST progression, intolerable toxicity, change to another anti-cancer treatment due to lack of apparent benefit, or personal choice.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSV | Drug |
Inclusion Criteria:
Ability to understand and sign a written informed consent form.
Measurable or evaluable disease with least one (1) tumor that is accessible to intratumoral injection.
Eastern Cooperative Group (ECOG) performance status is 0-3 at Screening.
Acceptable liver function at Screening, as evidenced by:
AST (SGOT) and ALT (SGPT) ≤ 5 X ULN.
Serum creatinine < 3 x institution upper limit of normal.
Patient has acceptable hematologic status at Screening, as evidenced by:
Medically acceptable contraception.
Willingness to comply with all protocol procedures, evaluations and rescue measures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Morris, MD | University of Cincinnati | Principal Investigator |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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