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NCT05077098 · ClinicalTrials.gov registry record · Phase 1
Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer
A Phase 1 study of Recurrent Prostate Cancer, sponsored by Mark Stein.
- Active
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT05077098 is a Phase 1 study of Recurrent Prostate Cancer that is active but no longer recruiting, run by Mark Stein. The registered enrollment target is 8 participants, below the 138-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05077098, a Phase 1 study of Recurrent Prostate Cancer, is active but no longer recruiting, sponsored by Mark Stein.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: \- To evaluate the safety and tolerability of ADXS-504 and to determine the MTD (maximum tolerated dose) or RP2D (recommended phase two dose) Secondary Objectives: * To characterize the immunological activity of ADXS-504, administered as; and to characterize the genomic profiles of study subjects * To evaluate the effects of ADXS-504 on change in PSA * To evaluate time to PSA progression
Conditions Studied
Interventions
- DRUG ADXS-504
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-08-12 |
| Est. Completion | 2028-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05077098
The ClinicalTrials.gov registry entry for NCT05077098 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 138-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (94% lower). The listed sponsor is Mark Stein, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Recurrent Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which ADXS-504 is the first listed.
NCT05077098 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05077098 about?
NCT05077098 is a clinical study titled "Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer". Primary Objective: \- To evaluate the safety and tolerability of ADXS-504 and to determine the MTD (maximum tolerated dose) or RP2D (recommended phase two dose) Secondary Objectives: * To characterize the immunological activity of ADXS-504, administered as; and to characterize the genomic profile...
What is the current status of trial NCT05077098?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-08-12. Estimated completion is 2028-07.
What conditions does trial NCT05077098 study?
This clinical trial studies the following conditions: Recurrent Prostate Cancer.
What interventions are being tested in trial NCT05077098?
The interventions under investigation include: ADXS-504 (DRUG).
Who is sponsoring clinical trial NCT05077098?
This trial is sponsored by Mark Stein, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05077098 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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