A Study of PRT2527 in Participants With Advanced Solid Tumors (NCT05159518) | Clinical Trial Compass
CompletedPhase 1
A Study of PRT2527 in Participants With Advanced Solid Tumors
United States30 participantsStarted 2022-02-14
Plain-language summary
This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors. The purpose of this study is to define the dosing schedule, and maximally tolerated dose to be used in subsequent development of PRT2527.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Selected sarcomas with a documented gene fusion
. Castrate resistant prostate cancer (CRPC)
. Hormone receptor positive (HR+), HER2 negative (HER2-) breast cancer
. Non-small cell lung cancer (NSCLC)
. MYC amplified solid tumors
Exclusion criteria
. Curatively treated malignancy with no known active disease
. Curatively treated non-melanoma skin cancer without evidence of disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose limiting toxicities (DLT) of PRT2527
Timeframe: Baseline through Day 21
2
Maximally tolerated dose (MTD) of PRT2527
Timeframe: Baseline through approximately 1 year
3
Recommended phase 2 dose (RP2D) and schedule of PRT2527