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A Study of PRT2527 in Participants With Advanced Solid Tumors

NCT ID: NCT05159518

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2023-12-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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Breast Cancer Castrate Resistant Prostate Cancer CDK9 Inhibitor CRPC Cyclin-dependent Kinase 9 Hormone Receptor Positive HER2 Negative Breast Cancer HR+/HER2- Breast Cancer Non-small Cell Lung Cancer NSCLC Prostate Cancer PRT2527 Refractory Solid Tumors Relapsed Solid Tumors Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRT2527

PRT2527 will be administered by intravenous infusion

Group Type EXPERIMENTAL

PRT2527

Intervention Type DRUG

PRT2527 will be administered by intravenous infusion

Interventions

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PRT2527

PRT2527 will be administered by intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prelude Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Site Status

Investigational Drug Services, AdventHealth Celebration

Celebration, Florida, United States

Site Status

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status

NEXT Virginia

Fairfax, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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PRT2527-01

Identifier Type: -

Identifier Source: org_study_id