A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors

Active:	No
Cancer Type:	Brain & Spinal Cord Tumor Lung Cancer Sarcoma	NCT ID:	NCT05538572
Trial Phases:	Phase I	Protocol IDs:	PRT3645-01 (primary) NCI-2022-09871
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Prelude Therapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT05538572

Summary

This is a Phase 1 dose-escalation study of PRT3645, a Cyclin-dependent Kinase 4/6
(CDK4/6) inhibitor, in patients with advanced or metastatic solid tumors. The purpose of
this study is to investigate the safety, tolerability, dose limiting toxicity, and to
determine maximally tolerated dose and recommended phase 2 dose to be used in subsequent
development of PRT3645.

Objectives

This is an open-label, multicenter, dose-escalation Phase 1 study of PRT3645, a CDK4/6
inhibitor, evaluating patients with selected advanced or metastatic solid tumors
including breast cancer (BC), glioblastoma (GBM), non-small cell lung cancer (NSCLC),
sarcomas, head and neck squamous cell carcinoma (HNSCC), malignant mesothelioma, and
endometrial cancer. The study plan expects to evaluate approximately eight dose levels
however additional 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. Up to 15 patients may be enrolled at a dose shown
to be tolerated for confirmation of the MTD and/or RP2D.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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