PRT13722 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This first-in-human, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally advanced or metastatic Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. PRT13722 will be evaluated as monotherapy and in combination with fulvestrant, abemaciclib plus fulvestrant, or imlunestrant to determine recommended dose(s) for expansion (RDE) and evaluate preliminary clinical activity.
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic HR+/HER2- breast cancer whose disease has worsened after standard treatments. Participants must be in good physical condition, have working major organs, and agree to use contraception. They also need to provide tumor samples for research.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
- Fulvestrant
- Imlunestrant
- PRT13722
Trial Overview
The study tests a new oral drug called PRT13722 alone and combined with other approved breast cancer medicines (fulvestrant, abemaciclib plus fulvestrant, or imlunestrant) to find the best dose and see how well it works against advanced HR+/HER2- breast cancer.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants receive PRT13722 once daily as monotherapy. This arm includes dose-escalation (Part 1A) and backfill cohorts (Part 1B) evaluating PRT13722 in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer to support the selection of RDE.
Participants receive PRT13722 once daily in combination with imlunestrant. This study includes a dose-escalation (Part 2C) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3C) at the RDE.
Participants receive PRT13722 once daily in combination with fulvestrant. This study includes a dose-escalation (Part 2A) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3A) at the RDE.
Participants receive PRT13722 once daily in combination with abemaciclib and fulvestrant. This study includes a dose-escalation (Part 2B) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3B) at the RDE.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prelude Therapeutics Incorporated
Lead Sponsor
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