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CDK9 Inhibitor

PRT2527 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Prelude Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through approximately 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what the highest dose patients can tolerate is.

Eligible Conditions
  • Sarcoma
  • Solid Tumors
  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities (DLT) of PRT2527
Maximally tolerated dose (MTD) of PRT2527
Recommended phase 2 dose (RP2D) and schedule of PRT2527
Secondary outcome measures
Anti-tumor activity of PRT2527: measurement of objective responses
Duration of response to PRT2527: Objective responses
Pharmacokinetic profile of PRT2527: maximum observed plasma concentration
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PRT2527Experimental Treatment1 Intervention
PRT2527 will be administered by intravenous infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRT2527
2022
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Prelude TherapeuticsLead Sponsor
8 Previous Clinical Trials
625 Total Patients Enrolled
2 Trials studying Sarcoma
48 Patients Enrolled for Sarcoma

Media Library

PRT2527 (CDK9 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05159518 — Phase 1
Sarcoma Research Study Groups: PRT2527
Sarcoma Clinical Trial 2023: PRT2527 Highlights & Side Effects. Trial Name: NCT05159518 — Phase 1
PRT2527 (CDK9 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159518 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects have enrolled in this research endeavor?

"30 subjects that meet the criteria for inclusion are sought to partake in this trial. These individuals can be found at NEXT Virginia located in Fairfax, VA and Sarah Cannon Research Institute based out of Denver, Colorado."

Answered by AI

To what end is this clinical experiment striving?

"This study will monitor the Maximum Tolerated Dose (MTD) of PRT2527 from Baseline to Day 21 as its primary outcome. Secondary objectives include quantifying anti-tumor activity, determining response duration and calculating maximum observed plasma concentration for pharmacokinetic purposes."

Answered by AI

Are there multiple American medical centers currently conducting this clinical investigation?

"The ongoing clinical trial is now accepting enrollees from 6 different locations. These cities include Fairfax, Denver and Sarasota in addition to 3 other places. To minimize the hassle of travelling for patients enrolled, it's advised that they select a site close by their residence."

Answered by AI

What potential health hazards are associated with PRT2527?

"Due to the limited scientific research on PRT2527, our team has assigned it a score of 1 in regards to safety. This is because this trial is only at Phase 1, indicating that there are not yet sufficient data points in favor of its efficacy and security."

Answered by AI

Is this clinical trial actively looking for participants?

"Data found on clinicaltrials.gov attests to the fact that this medical trial is still open for recruitment, which began on February 14th 2022 and underwent a recent update on June 9th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Sarah Cannon Research Institute at HealthONE
Thomas Jefferson University, Sidney Kimmel Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~9 spots leftby Apr 2025