Breast Cancer Clinical Trial

A Study of PRT2527 in Patients With Advanced Solid Tumors

Summary

This is a Phase 1 dose-escalation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in patients 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.

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Full Description

This is a multicenter, open-label, dose-escalation Phase 1 study of PRT2527, a CDK9 inhibitor, evaluating patients with selected advanced/metastatic sarcomas displaying a gene fusion, castrate resistant prostate cancer, hormone positive Her2-negative breast cancer, advanced/metastatic non-small cell lung cancer, and solid tumors displaying MYC amplification. The study plan expects to evaluate approximately six dose levels of approximately 1-6 patients per dose level; however additional dose levels may be explored. Taking into account pharmacokinetic and pharmacodynamic data from the preceding dose levels, the dose may be escalated until a dose limiting toxicity is identified. The total sample size will be approximately 30 patients for MTD and RP2D determination.

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Eligibility Criteria

Inclusion Criteria:

Tumor types under study

Selected Sarcomas (Ewing Sarcoma; Synovial Sarcoma; Myxoid/Round Cell Liposarcoma) with a gene fusion
Castrate Resistant Prostate Cancer
Hormone Positive, HER2 Negative Breast Cancer
Advanced Non-Small Cell Lung Cancer
MYC Amplified Solid Tumors
Must have measurable disease per RECIST 1.1; patients with prostate cancer may have 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
Except for alopecia, all patients must have recovered from the effects of any prior cancer related therapy, radiotherapy, or surgery (toxicity from prior therapy is not greater than Grade 1)

Exclusion Criteria:

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05159518

Recruitment Status:

Recruiting

Sponsor:

Prelude Therapeutics

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There are 6 Locations for this study

See Locations Near You

Sarah Cannon Research Institute at HealthONE
Denver Colorado, 80218, United States
Investigational Drug Services, AdventHealth Celebration
Celebration Florida, 34747, United States
Florida Cancer Specialists
Sarasota Florida, 34232, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia Pennsylvania, 19107, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
NEXT Virginia
Fairfax Virginia, 22031, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05159518

Recruitment Status:

Recruiting

Sponsor:


Prelude Therapeutics

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