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NCT03262103 · ClinicalTrials.gov registry record · Phase 1

Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer

A Phase 1 study, sponsored by Ashutosh Kumar Tewari.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT03262103 is a Phase 1 study that has completed, run by Ashutosh Kumar Tewari. The registered enrollment target is 13 participants.

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The verdict

NCT03262103, a Phase 1 study, has completed, sponsored by Ashutosh Kumar Tewari.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

The purpose of this study is to test an approach of stimulating the body's immune system to attack prostate cancer. This study will test injection of a substance polylysine and carboxymethylcellulose (Poly-ICLC, Hiltonol®)through a needle guided by MRI (magnetic resonance imaging) ultrasound fusion technology into the prostate gland. Poly ICLC has been used to help the body in its fight against cancer. The first aim of the study is to determine the highest dose of a substance Poly-ICLC (Hiltonol®) that can be safely tolerated by the study participants. The second aim of the study is to find out the toxicity or side effects of poly-ICLC.

Interventions

  • PROCEDURE Radical Prostatectomy
  • BIOLOGICAL Intratumoral (IT) Poly ICLC 0.5 mg
  • BIOLOGICAL Intratumoral (IT) Poly ICLC 1.0 mg
  • BIOLOGICAL Intramuscular (IM) Poly ICLC

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2017-06-16
Est. Completion 2022-05-06
Phase Phase 1

Sponsor

Ashutosh Kumar Tewari

3 total trials

What the Registry Record Tells You About NCT03262103

The ClinicalTrials.gov registry entry for NCT03262103 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ashutosh Kumar Tewari, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Radical Prostatectomy is the first listed.

NCT03262103 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03262103 about?

NCT03262103 is a clinical study titled "Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer". The purpose of this study is to test an approach of stimulating the body's immune system to attack prostate cancer. This study will test injection of a substance polylysine and carboxymethylcellulose (Poly-ICLC, Hiltonol®)through a needle guided by MRI (magnetic resonance imaging) ultrasound fusion ...

What is the current status of trial NCT03262103?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2017-06-16. Estimated completion is 2022-05-06.

What interventions are being tested in trial NCT03262103?

The interventions under investigation include: Radical Prostatectomy (PROCEDURE), Intratumoral (IT) Poly ICLC 0.5 mg (BIOLOGICAL), Intratumoral (IT) Poly ICLC 1.0 mg (BIOLOGICAL), Intramuscular (IM) Poly ICLC (BIOLOGICAL).

Who is sponsoring clinical trial NCT03262103?

This trial is sponsored by Ashutosh Kumar Tewari, which has 3 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.