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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT05538572

Public ClinicalTrials.gov record NCT05538572. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 3:00 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05538572
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
22 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 27, 2022 (Actual)
Primary completion
Jun 26, 2024 (Actual)
Completion
Jun 26, 2024 (Actual)
Last update posted
Jul 1, 2024

2022 – 2024

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
11
Facility City State ZIP Site status
Smilow Cancer Hospital Phase 1 Unit New Haven Connecticut 06511 —
AdventHealth Medical Group Oncology Research at Celebration Celebration Florida 34747 —
Miami Cancer Institute Miami Florida 33176 —
Florida Cancer Specialists Sarasota Florida 34232 —
Winship Cancer Institute, Emory University Atlanta Georgia 30322 —
Laura and Isaac Perlmutter Cancer Center/ NYU Langone Health New York New York 10016 —
Cleveland Clinic Cleveland Ohio 44195 —
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 —
Thomas Jefferson University, Sidney Kimmel Cancer Center Philadelphia Pennsylvania 19107 —
Tennessee Oncology, PLLC Nashville Tennessee 37203 —
South Texas Accelerated Research Therapeutics, LLC San Antonio Texas 78229 —
NEXT Virginia Fairfax Virginia 22031 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05538572, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 1, 2024 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05538572 live on ClinicalTrials.gov.

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