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NCT05010200 · ClinicalTrials.gov registry record · Phase 1
The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting.
A Phase 1 study of Prostate Cancer, sponsored by Ashutosh Kumar Tewari.
- Active
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT05010200: Active Phase 1 study of Prostate Cancer, sponsored by Ashutosh Kumar Tewari.
NCT05010200 is a Phase 1 study of Prostate Cancer that is active but no longer recruiting, run by Ashutosh Kumar Tewari. The registered enrollment target is 27 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05010200, a Phase 1 study of Prostate Cancer, is active but no longer recruiting, sponsored by Ashutosh Kumar Tewari.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting.
Primary Outcome
Adverse events will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v5.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale .
Conditions Studied
Interventions
- BIOLOGICAL CDX-301
- BIOLOGICAL PGV-001
- BIOLOGICAL Poly-ICLC
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai (ISMMS) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2022-01-05 |
| Est. Completion | 2028-01 |
| Phase | Phase 1 |
What the registry record for NCT05010200 still lists
NCT05010200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which CDX-301 is the first listed.
NCT05010200 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05010200 about?
NCT05010200 is a clinical study titled "The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting.". This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting.
What is the current status of trial NCT05010200?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2022-01-05. Estimated completion is 2028-01.
What conditions does trial NCT05010200 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT05010200?
The interventions under investigation include: CDX-301 (BIOLOGICAL), PGV-001 (BIOLOGICAL), Poly-ICLC (BIOLOGICAL).
Who is sponsoring clinical trial NCT05010200?
This trial is sponsored by Ashutosh Kumar Tewari, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05010200 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05010200's enrollment target sits among peer trials
27 615th of 735 higher than 114 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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