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A Study of PRT2527 in Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05159518
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : January 5, 2023
Information provided by (Responsible Party):
Prelude Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Sarcoma Castrate Resistant Prostate Cancer Hormone Receptor Positive HER2 Negative Breast Cancer Non-small Cell Lung Cancer Solid Tumors With Known MYC Amplification Drug: PRT2527 Phase 1

Detailed Description:
This is a multicenter, open-label, dose-escalation and confirmation Phase 1 study of PRT2527, a CDK9 inhibitor, evaluating participants with selected advanced/metastatic sarcomas displaying a documented gene fusion, castrate resistant prostate cancer, hormone receptor 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 participants per dose level; however additional and/or intermediate 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation and Confirmation Study of PRT2527 in Participants With Advanced Solid Tumors
Actual Study Start Date : February 14, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: PRT2527
PRT2527 will be administered by intravenous infusion
Drug: PRT2527
PRT2527 will be administered by intravenous infusion

Primary Outcome Measures :
  1. Dose limiting toxicities (DLT) of PRT2527 [ Time Frame: Baseline through Day 21 ]
    Dose limiting toxicities will be evaluated over the 21-day observation period

  2. Maximally tolerated dose (MTD) of PRT2527 [ Time Frame: Baseline through approximately 1 year ]
    The MTD will be established for further investigation in participants with advanced solid tumors

  3. Recommended phase 2 dose (RP2D) and schedule of PRT2527 [ Time Frame: Baseline through approximately 1 year ]
    The RP2D will be established for further investigation in participants with advanced solid tumors

Secondary Outcome Measures :
  1. Safety and tolerability of PRT2527: AEs, SAEs, CTCAE assessments [ Time Frame: Baseline through approximately 2 years ]
    Safety and tolerability will be assessed by recording adverse events (AEs) and serious adverse events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE)

  2. Pharmacokinetic profile of PRT2527: maximum observed plasma concentration [ Time Frame: Baseline through approximately 1 year ]
    PRT2527 pharmacokinetics will be calculated including the maximum observed plasma concentration

  3. Anti-tumor activity of PRT2527: measurement of objective responses [ Time Frame: Baseline through approximately 2 years ]
    Anti-tumor activity of PRT2527 based on the measurement of objective responses to PRT2527 according to the disease-specific response criteria for patients with advanced solid tumors

  4. Duration of response to PRT2527: Objective responses [ Time Frame: Baseline through approximately 2 years ]
    Duration of response will be calculated for all patients eligible for response determination from the time that a response is first observed until progression or death, whichever occurs first

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05159518

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Contact: Study Contact (Please Do Not Disclose Personal Information) See Email PRT2527-01IVstudy@preludetx.com

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United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Investigational Drug Services, AdventHealth Celebration Recruiting
Celebration, Florida, United States, 34747
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Pennsylvania
Thomas Jefferson University, Sidney Kimmel Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
United States, Virginia
NEXT Virginia Recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Prelude Therapeutics
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Responsible Party: Prelude Therapeutics
ClinicalTrials.gov Identifier: NCT05159518    
Other Study ID Numbers: PRT2527-01
First Posted: December 16, 2021    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prelude Therapeutics:
Breast Cancer
Castrate Resistant Prostate Cancer
CDK9 Inhibitor
Cyclin-dependent Kinase 9
Hormone Receptor Positive HER2 Negative Breast Cancer
HR+/HER2- Breast Cancer
Non-small Cell Lung Cancer
Prostate Cancer
Refractory Solid Tumors
Relapsed Solid Tumors
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Breast Diseases
Skin Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type