Expanded Access for PSV Personalized Oncolytic Viruses (PSV)

A compassionate use, expanded access protocol for patients who have exhausted all standard therapy having progressed on chemotherapy and immunotherapy.

Study Overview

• Status: No longer available
• Conditions: Cancer
• Intervention / Treatment: Drug: PSV

Detailed Description

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.

• Study Type: Expanded Access
• Expanded Access Type: Individual Patients

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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:

  • Bilirubin ≤ 3.0 X upper limit of normal (ULN) since this patient has
  • been diagnosed with Gilbert's Disease
• 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:

  • Absolute neutrophil count ≥ 1,500 cells/mm3; and
  • Platelet count ≥ 70,000/mm3; and
  • Hemoglobin (HGB) ≥ 8.5 g/dL.
• Medically acceptable contraception.
• Willingness to comply with all protocol procedures, evaluations and rescue measures.

Exclusion Criteria:

• Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.
• An active bacterial, fungal, or viral infection.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: EpicentRx, Inc.
• Investigators: Principal Investigator: John Morris, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Cancer
• Other Study ID Numbers: PSV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No