A Study of PRT2527 in Participants With Advanced Solid Tumors

NCT05159518 | Completed Phase 1 FDA Drug

• 1 other identifier: PRT2527-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicities (DLT) of PRT2527

  Dose limiting toxicities will be evaluated over the 21-day observation period

  Baseline through Day 21

• Maximally tolerated dose (MTD) of PRT2527

  The MTD will be established for further investigation in participants with advanced solid tumors

  Baseline through approximately 1 year

• Recommended phase 2 dose (RP2D) and schedule of PRT2527

  The RP2D will be established for further investigation in participants with advanced solid tumors

  Baseline through approximately 1 year

Secondary Outcomes (4)

• Safety and tolerability of PRT2527: AEs, SAEs, CTCAE assessments

  Baseline through approximately 2 years

• Pharmacokinetic profile of PRT2527: maximum observed plasma concentration

  Baseline through approximately 1 year

• Anti-tumor activity of PRT2527: measurement of objective responses

  Baseline through approximately 2 years

• Duration of response to PRT2527: Objective responses

  Baseline through approximately 2 years

Study Arms (1)

PRT2527

EXPERIMENTAL

PRT2527 will be administered by intravenous infusion

Drug: PRT2527

Interventions

PRT2527 DRUG

PRT2527 will be administered by intravenous infusion

PRT2527

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Prelude Therapeutics: lead

Study Sites (8)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Investigational Drug Services, AdventHealth Celebration

Celebration, Florida, 34747, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Sarcoma; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 16, 2021
• Study Start: February 14, 2022
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

US (8)