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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
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Status (KPS) ≥80% (KPS is for GBM only)
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 belowSelect...
I can swallow and keep down pills.
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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.
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
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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or able to carry out light work.I can swallow and keep down pills.My organs are working well.My cancer has progressed or can't be treated with standard therapies.My cancer can be measured or observed by doctors.I can provide a sample of my tumor, either previously stored or newly taken.I do not have uncontrolled heart issues, electrolyte disorders, or severe brain/spinal cord disease.I have a condition that affects how my body absorbs medication.I have endometrial cancer and was treated with a CDK 4/6 inhibitor.My advanced cancer has spread widely and is causing symptoms.I haven't had any cancer except for certain skin cancers or other specific non-aggressive types in the last 3 years.I am not taking medications that strongly affect liver enzymes.
Research Study Groups:
This trial has the following groups:- Group 1: PRT3645
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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
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