A Study of PRT2527 in Patients With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 dose-escalation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in patients 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prelude Therapeutics

Criteria

Inclusion Criteria:

• Histologically confirmed advanced or metastatic solid tumor indicated below that is relapsed, refractory, or intolerant to available therapies with known benefit:

1. Sarcomas of any histology

2. Castrate resistant prostate cancer

3. ER Positive Breast Cancer and Triple Negative Breast Cancer

4. Solid tumors with known MYC amplification

• Must have measurable disease; patients with breast and 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

• Must have recovered from the effects of any prior cancer related therapy, radiotherapy, or surgery (toxicity no greater than Grade 1)

Exclusion Criteria:

• Primary malignancies of the CNS, or uncontrolled CNS metastases, including impending spinal cord compression

• Prolonged QT interval

• 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 or lentigo maligna without evidence of disease

3. Curatively treated carcinoma in situ without evidence of disease