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A Study of PRT2527 in Participants With Advanced Solid Tumors

Primary Purpose

Sarcoma, Castrate Resistant Prostate Cancer, Hormone Receptor Positive HER2 Negative Breast Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRT2527
Sponsored by
Prelude Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Tumor types under study

    1. Selected Sarcomas (Ewing Sarcoma; Synovial Sarcoma; Myxoid/Round Cell Liposarcoma) with a gene fusion
    2. Castrate Resistant Prostate Cancer
    3. Hormone Positive, HER2 Negative Breast Cancer
    4. Advanced Non-Small Cell Lung Cancer
    5. 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:

    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.

Sites / Locations

  • Sarah Cannon Research Institute at HealthONE
  • Investigational Drug Services, AdventHealth Celebration
  • Florida Cancer Specialists
  • Memorial Sloan Kettering Cancer Center
  • Thomas Jefferson University, Sidney Kimmel Cancer Center
  • Fox Chase Cancer Center
  • Mary Crowley Cancer Research
  • NEXT Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRT2527

Arm Description

PRT2527 will be administered by intravenous infusion

Outcomes

Primary Outcome Measures

Dose limiting toxicities (DLT) of PRT2527
Dose limiting toxicities will be evaluated over the 21-day observation period
Maximally tolerated dose (MTD) of PRT2527
The MTD will be established for further investigation in participants with advanced solid tumors
Recommended phase 2 dose (RP2D) and schedule of PRT2527
The RP2D will be established for further investigation in participants with advanced solid tumors

Secondary Outcome Measures

Safety and tolerability of PRT2527: AEs, SAEs, CTCAE assessments
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)
Pharmacokinetic profile of PRT2527: maximum observed plasma concentration
PRT2527 pharmacokinetics will be calculated including the maximum observed plasma concentration
Anti-tumor activity of PRT2527: measurement of objective responses
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
Duration of response to PRT2527: Objective responses
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

Full Information

First Posted
December 2, 2021
Last Updated
August 4, 2023
Sponsor
Prelude Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05159518
Brief Title
A Study of PRT2527 in Participants With Advanced Solid Tumors
Official Title
A Phase 1, Open-Label, Multicenter, Dose Escalation and Confirmation Study of PRT2527 in Participants With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prelude Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Castrate Resistant Prostate Cancer, Hormone Receptor Positive HER2 Negative Breast Cancer, Non-small Cell Lung Cancer, Solid Tumors With Known MYC Amplification
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRT2527
Arm Type
Experimental
Arm Description
PRT2527 will be administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
PRT2527
Intervention Description
PRT2527 will be administered by intravenous infusion
Primary Outcome Measure Information:
Title
Dose limiting toxicities (DLT) of PRT2527
Description
Dose limiting toxicities will be evaluated over the 21-day observation period
Time Frame
Baseline through Day 21
Title
Maximally tolerated dose (MTD) of PRT2527
Description
The MTD will be established for further investigation in participants with advanced solid tumors
Time Frame
Baseline through approximately 1 year
Title
Recommended phase 2 dose (RP2D) and schedule of PRT2527
Description
The RP2D will be established for further investigation in participants with advanced solid tumors
Time Frame
Baseline through approximately 1 year
Secondary Outcome Measure Information:
Title
Safety and tolerability of PRT2527: AEs, SAEs, CTCAE assessments
Description
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)
Time Frame
Baseline through approximately 2 years
Title
Pharmacokinetic profile of PRT2527: maximum observed plasma concentration
Description
PRT2527 pharmacokinetics will be calculated including the maximum observed plasma concentration
Time Frame
Baseline through approximately 1 year
Title
Anti-tumor activity of PRT2527: measurement of objective responses
Description
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
Time Frame
Baseline through approximately 2 years
Title
Duration of response to PRT2527: Objective responses
Description
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
Time Frame
Baseline through approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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.
Facility Information:
Facility Name
Sarah Cannon Research Institute at HealthONE
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Investigational Drug Services, AdventHealth Celebration
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Thomas Jefferson University, Sidney Kimmel Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
NEXT Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

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A Study of PRT2527 in Participants With Advanced Solid Tumors

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