A Study of PRT2527 in Participants With Advanced Solid Tumors

Prelude Therapeutics

Status and phase

Completed

Phase 1

Conditions

Sarcoma

Non-small Cell Lung Cancer

Hormone Receptor Positive HER2 Negative Breast Cancer

Solid Tumors With Known MYC Amplification

Castrate Resistant Prostate Cancer

Treatments

Drug: PRT2527

Study type

Interventional

Funder types

Industry

Identifiers

NCT05159518

PRT2527-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.