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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: Completed Phase 1 study, sponsored by Ashutosh Kumar Tewari.
NCT03262103 is a Phase 1 study that has completed, run by Ashutosh Kumar Tewari. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
3+3 dose escalation rules to define a safe dose of preoperative intratumoral (IT) plus intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC, Hiltonol®) prior to radical prostatectomy
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
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-06-16 |
| Est. Completion | 2022-05-06 |
| Phase | Phase 1 |
What the finished NCT03262103 record still lists
NCT03262103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Radical Prostatectomy is the first listed.
NCT03262103 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03262103's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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