Expanded Access for PSV Personalized Oncolytic Viruses

• Conditions: Cancer

• Registration Number: NCT03529539
• Lead Sponsor: EpicentRx, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-18
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified