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NCT05538572 · ClinicalTrials.gov registry record · Phase 1
A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by Prelude Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT05538572: Completed Phase 1 study, sponsored by Prelude Therapeutics.
NCT05538572 is a Phase 1 study that has completed, run by Prelude Therapeutics. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05538572, a Phase 1 study, has completed, sponsored by Prelude Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This is a Phase 1 dose-escalation study of PRT3645, a Cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, in patients with advanced or metastatic solid tumors. The purpose of this study is to investigate the safety, tolerability, dose limiting toxicity, and to determine maximally tolerated dose and recommended phase 2 dose to be used in subsequent development of PRT3645.
Primary Outcome
Dose limiting toxicity will be evaluated over the 28-day observation period
Interventions
- DRUG PRT3645
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-12-27 |
| Est. Completion | 2024-06-26 |
| Phase | Phase 1 |
What the finished NCT05538572 record still lists
NCT05538572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which PRT3645 is the first listed.
NCT05538572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05538572 about?
NCT05538572 is a clinical study titled "A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors". This is a Phase 1 dose-escalation study of PRT3645, a Cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, in patients with advanced or metastatic solid tumors. The purpose of this study is to investigate the safety, tolerability, dose limiting toxicity, and to determine maximally tolerated dose and reco...
What is the current status of trial NCT05538572?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2022-12-27. Estimated completion is 2024-06-26.
What interventions are being tested in trial NCT05538572?
The interventions under investigation include: PRT3645 (DRUG).
Who is sponsoring clinical trial NCT05538572?
This trial is sponsored by Prelude Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05538572's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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