PRT13722 in advanced HR+/HER2- breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label, multicenter phase 1/1b trial investigates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of the oral KAT6A degrader PRT13722 in adults with locally advanced or metastatic HR+/HER2- breast cancer. Participants may receive PRT13722 as monotherapy or in combination with fulvestrant, abemaciclib plus fulvestrant, or imlunestrant to establish recommended dose levels for expansion and to gauge early clinical activity. The study includes dose-escalation to identify DLTs, followed by dose-expansion cohorts to further assess safety and signals of efficacy across three parts, with up to ~240 participants planned. Key endpoints include safety, pharmacokinetics, pharmacodynamics, and preliminary tumor responses per RECIST v1.1.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures.
* histological or cytological diagnosis of locally advanced or metastatic HR-positive/HER2-negative breast cancer
* Disease progression following prior standard therapy and eligible for the assigned study cohort
* Measurable or evaluable disease per RECIST v1.1
* Willingness to provide tumor tissue for biomarker analyses
* Eastern Cooperative Oncology Group performance status of 0-1
* Negative serum or urine pregnancy test and agree to use highly effective contraception or maintain true abstinence.
* Adequate organ function and bone marrow reserves (hematology, renal, and hepatic)

Exclusion Criteria:

* Untreated, symptomatic, or unstable brain metastases
* Symptomatic visceral disease at risk of imminent life-threatening complications
* Uncontrolled infection or significant concurrent medical conditions
* Clinically significant cardiovascular disease or prolonged QT syndrome
* Pregnancy or breastfeeding
* Prior treatment with a KAT6-targeting agent
* Recent anticancer therapy, radiotherapy, or major surgery
* Use of prohibited concomitant medications, including strong CYP3A4 inhibitors or inducers, proton pump inhibitors, P-gp inhibitors or inducers, and breast cancer resistance protein inhibitors
* Participation in another interventional clinical study
* Any condition that would interfere with study participation or evaluation of study results

Where it's running

• Taylor Cancer Research Center
  Maumee, Ohio, United States Recruiting

Study contacts

• Study coordinator: Study Contact (Please Do Not Disclose Personal Information)
• Email: clinicaltrials@preludetx.com
• Phone: See Email

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.