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NCT05639751 · ClinicalTrials.gov registry record · Phase 1
PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation
A Phase 1 study, sponsored by Prelude Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 135
- Enrollment target
NCT05639751: Completed Phase 1 study, sponsored by Prelude Therapeutics.
NCT05639751 is a Phase 1 study that has completed, run by Prelude Therapeutics. The registered enrollment target is 135 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05639751, a Phase 1 study, has completed, sponsored by Prelude Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 135 participants
- Enrollment target
Study Summary
This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789.
Primary Outcome
Dose limiting toxicities will be evaluated over the 21-day observation period
Interventions
- DRUG Docetaxel
- DRUG PRT3789
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2023-05-02 |
| Est. Completion | 2025-10-01 |
| Phase | Phase 1 |
What the finished NCT05639751 record still lists
NCT05639751 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT05639751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05639751 about?
NCT05639751 is a clinical study titled "PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation". This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynam...
What is the current status of trial NCT05639751?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 135 participants. The study started on 2023-05-02. Estimated completion is 2025-10-01.
What interventions are being tested in trial NCT05639751?
The interventions under investigation include: Docetaxel (DRUG), PRT3789 (DRUG).
Who is sponsoring clinical trial NCT05639751?
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 NCT05639751's enrollment target sits among peer trials
135 425th of 2000 higher than 1,574 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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