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NCT05865028 · ClinicalTrials.gov registry record · Phase 2
A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
A Phase 2 study of Oropharyngeal Dysplasia and Oral Cavity Dysplasia, sponsored by Elizabeth J Franzmann.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT05865028: Recruiting Phase 2 study of Oropharyngeal Dysplasia and Oral Cavity Dysplasia, sponsored by Elizabeth J Franzmann.
NCT05865028 is a Phase 2 study of Oropharyngeal Dysplasia and Oral Cavity Dysplasia that is actively recruiting participants, run by Elizabeth J Franzmann. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05865028, a Phase 2 study of Oropharyngeal Dysplasia and Oral Cavity Dysplasia, is actively recruiting participants, sponsored by Elizabeth J Franzmann.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess whether APG-157 can reduce the tumor size in participants with the study disease. Another purpose is to find out about the effects of APG-157 on certain tumor markers and oral rinses in participants with the study disease.
Primary Outcome
The pathologic response rate among participants receiving study treatment will be assessed. The pathologic response rate is defined as the percentage of participants with mild or no dysplasia after receiving study therapy. Response will be assessed on the basis of clinical, radiologic, molecular and pathologic criteria consistent with Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria, per physician discretion.
Conditions Studied
Interventions
- DRUG APG-157
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-05-24 |
| Est. Completion | 2028-05-24 |
| Phase | Phase 2 |
What NCT05865028 shows while recruiting
NCT05865028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 3 conditions, with Oropharyngeal Dysplasia appearing as the primary indexed condition, and to 1 intervention - of which APG-157 is the first listed.
NCT05865028 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05865028 about?
NCT05865028 is a clinical study titled "A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia". The purpose of this study is to assess whether APG-157 can reduce the tumor size in participants with the study disease. Another purpose is to find out about the effects of APG-157 on certain tumor markers and oral rinses in participants with the study disease.
What is the current status of trial NCT05865028?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2023-05-24. Estimated completion is 2028-05-24.
What conditions does trial NCT05865028 study?
This clinical trial studies the following conditions: Oropharyngeal Dysplasia, Oral Cavity Dysplasia, Oral Carcinoma in Situ.
What interventions are being tested in trial NCT05865028?
The interventions under investigation include: APG-157 (DRUG).
Who is sponsoring clinical trial NCT05865028?
This trial is sponsored by Elizabeth J Franzmann, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05865028 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05865028's enrollment target sits among peer trials
32 1563rd of 2000 higher than 424 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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