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
404-778-5180
winshipcancer.emory.edu

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