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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: Active Phase 1 study of Recurrent Prostate Cancer, sponsored by Mark Stein.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To determine safety and tolerability profile of ADXS-504 of the investigational product
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 |
What the registry record for NCT05077098 still lists
NCT05077098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 138-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Recurrent 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 NCT05077098's enrollment target sits among peer trials
8 22nd of 21 the lowest of 21 other Recurrent Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent 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.
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