Expanded Access for PSV Personalized Oncolytic Viruses

NCT ID: NCT03529539

Last Updated: 2019-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PSV

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

EpicentRx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Morris, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PSV

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.