Expanded Access for PSV Personalized Oncolytic Viruses

Cancer Clinical Trial

— PSV  

Official title:

Expanded Access for PSV Personalized Oncolytic Viruses

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03529539
• Other study ID #: PSV
• Status: No longer available

Study information

• Verified date: March 2019
• Source: EpicentRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• PSV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EpicentRx, Inc.