A Study of PRT2527 in Participants With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Sarcoma, Castrate Resistant Prostate Cancer, Hormone Receptor Positive HER2 Negative Breast Cancer, Non-small Cell Lung Cancer, Solid Tumors With Known MYC Amplification

In brief

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.

Key facts

Study ID

NCT05159518

Run by

Prelude Therapeutics

People needed

30

Starts

2022-02-14

Expected to finish

2023-12-06

Last updated by the study team

2023-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Tumor types under study
• 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
• 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

You may not qualify if…

• 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:
• Curatively treated malignancy with no known active disease
• Curatively treated non-melanoma skin cancer without evidence of disease
• 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.

Where it is running

• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
• Investigational Drug Services, AdventHealth Celebration — Celebration, Florida, United States
• Florida Cancer Specialists — Sarasota, Florida, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• NEXT Virginia — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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