Your session is about to expire
← Back to Search
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)
Must not have
Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic CNS metastases or leptomeningeal disease except for GBM
Endometrial cancer patients who had received prior treatment with a CDK 4/6 inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests PRT3645, a drug that blocks proteins helping cancer cells grow, in patients with advanced or spreading cancers not responding to other treatments. It aims to find the safest dose and see how well patients tolerate it.
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.
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.
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.
Select...
I am fully active or able to carry out light work.
Select...
My cancer has progressed or can't be treated with standard therapies.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled heart issues, electrolyte disorders, or severe brain/spinal cord disease.
Select...
I have endometrial cancer and was treated with a CDK 4/6 inhibitor.
Select...
My advanced cancer has spread widely and is causing symptoms.
Select...
I am not taking medications that strongly affect liver enzymes.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Efficacy of PRT3645: Tumor assessment and responses
Pharmacodynamic effect of PRT3645: Target engagement
Pharmacokinetic profile of PRT3645: Minimum and maximum observed plasma concentration
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRT3645
2022
Completed Phase 1
~30
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cyclin-dependent Kinase 4/6 (CDK4/6) inhibitors, such as PRT3645, target proteins essential for cell cycle progression from the G1 to the S phase. By inhibiting CDK4/6, these drugs prevent phosphorylation of the retinoblastoma protein (Rb), thereby halting cell division and inducing cell cycle arrest.
This mechanism is particularly significant for breast cancer patients with hormone receptor-positive (HR+)/HER2-negative (HER2-) subtypes, as these cancers often rely on CDK4/6 for proliferation. By effectively stopping cancer cell growth, CDK4/6 inhibitors can improve progression-free survival and offer a targeted treatment option with potentially fewer side effects compared to traditional chemotherapy.
CDK4/6 Inhibitors in Combination With Hormone Therapy for HR<sup>+</sup>/HER2<sup>-</sup> Advanced Breast Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials.
CDK4/6 Inhibitors in Combination With Hormone Therapy for HR<sup>+</sup>/HER2<sup>-</sup> Advanced Breast Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials.
Find a Location
Who is running the clinical trial?
Prelude TherapeuticsLead Sponsor
9 Previous Clinical Trials
975 Total Patients Enrolled
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.
Share this study with friends
Copy Link
Messenger