A Study of PRT2527 in Participants With Advanced Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 11, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Prelude Therapeutics
- Interventions being studied
- Drug: PRT2527
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Tumor types under study 1. Selected sarcomas with a documented gene fusion 2. Castrate resistant prostate cancer (CRPC) 3. Hormone receptor positive (HR+), HER2 negative (HER2-) breast cancer 4. Non-small cell lung cancer (NSCLC) 5. MYC amplified solid tumors
- Must have measurable disease per RECIST 1.1; participants with CRPC or sarcoma may have nonmeasurable but evaluable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
- Adequate organ function
- Must provide tumor tissue sample to the central laboratory for biomarker analysis
- Participants must have recovered from the effects of prior cancer-related therapy, radiotherapy, or surgery to ≤ Grade 1
- Primary malignancies of the CNS, or uncontrolled CNS metastases, including impending spinal cord compression
- have a corrected QT interval \>480 msec from prior or baseline
- have impaired cardiac function or clinically significant cardiac disease
- Treatment with strong inhibitors or inducers of CYP3A4
- Prior exposure to a CDK9 inhibitor
- History of another malignancy except for: 1. Curatively treated malignancy with no known active disease 2. Curatively treated non-melanoma skin cancer without evidence of disease 3. Curatively treated carcinoma in situ without evidence of disease
- have undergone major surgery within 2 weeks prior to Week 1 Day 1
- have had chemotherapy, biologic therapy, targeted therapy, immunotherapy, extended-field radiotherapy, or investigational agents within 5 half-lives or 28 days (whichever is shorter) prior to administration of the first dose of study drug on Week 1 Day 1.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Investigational Drug Services, AdventHealth CelebrationCelebration, Florida
- Florida Cancer SpecialistsSarasota, Florida
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, Pennsylvania
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania
- Mary Crowley Cancer ResearchDallas, Texas
- NEXT VirginiaFairfax, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 11, 2023. Always confirm current availability with the study team.