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CDK4/6 Inhibitor

PRT3645 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Prelude Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to swallow and retain oral medication

Adequate organ function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through approximately 2 years

Awards & highlights

Study Summary

This trial will test a new drug to see if it's safe and effective for people with advanced cancer. It will measure safety, side effects, and the best dose to use.

Who is the study for?

This trial is for adults with certain advanced or metastatic solid tumors, including specific types of breast cancer, brain tumors, lung cancer, head and neck cancers, sarcoma, and endometrial cancer. Participants must have progressed beyond standard treatments or be ineligible for them. They should be in good physical condition (ECOG 0-1), able to provide a tumor tissue sample, comply with study procedures and have adequate organ function.Check my eligibility

What is being tested?

PRT3645 is being tested in this Phase 1 trial. It's a new drug aimed at inhibiting CDK4/6 which are proteins involved in cell division. The study will gradually increase doses to find the highest dose patients can take without serious side effects (maximally tolerated dose) and decide on the best dose for future studies.See study design

What are the potential side effects?

As PRT3645 is still under investigation, potential side effects include those commonly associated with CDK4/6 inhibitors such as nausea, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems; fatigue; hair thinning; liver issues; mouth sores.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow and keep down pills.

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My organs are working well.

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I am fully active or able to carry out light work.

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My cancer has progressed or can't be treated with standard therapies.

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My cancer can be measured or observed by doctors.

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I can provide a sample of my tumor, either previously stored or newly taken.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose limiting toxicity (DLT) of PRT3645

Maximally tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of PRT3645

Safety and tolerability of PRT3645: AEs, CTCAE Assessments

Secondary outcome measures

Efficacy of PRT3645: Tumor assessment and responses

Pharmacodynamic effect of PRT3645: Target engagement

Pharmacokinetic profile of PRT3645: Minimum and maximum observed plasma concentration

Trial Design

1Treatment groups

Experimental Treatment

Group I: PRT3645Experimental Treatment1 Intervention

PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Prelude TherapeuticsLead Sponsor

8 Previous Clinical Trials

633 Total Patients Enrolled

1 Trials studying Breast Cancer

26 Patients Enrolled for Breast Cancer

Media Library

PRT3645 (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05538572 — Phase 1

Breast Cancer Research Study Groups: PRT3645

Breast Cancer Clinical Trial 2023: PRT3645 Highlights & Side Effects. Trial Name: NCT05538572 — Phase 1

PRT3645 (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538572 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are involved in this trial thus far?

"This trial requires 51 participants that meet the eligibility requirements. Patients may join from sites such as NEXT Virginia in Fairfax, VA or Tennessee Oncology PLLC located in Nashville, TN."

Answered by AI

Is enrollment for this experiment still open?

"Per the information available on clinicaltrials.gov, this medical trial is open for recruitment; it was initially posted back in December 1st 2022 and updated lastly on November 29th of the same year."

Answered by AI

Has the FDA granted its blessing to PRT3645?

"The safety of PRT3645 is preliminarily assessed at 1, as it is a Phase 1 trial and there are only limited data available about its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05538572.

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