Tests PRT13722 in adults with advanced HR+/HER2- breast cancer
Tests PRT13722 alone and with other drugs in advanced breast cancer.
Plain-language title generated from the registry record
Registry title: A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
Key facts
- Where
- Maumee, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Taylor Cancer Research CenterMaumee, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Prelude Therapeutics Incorporated
- Trial code
- NCT07905001EU 2026-527825-37-00
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 1/1b, First-in-Human, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PRT13722, a KAT6A Protein Degrader, as Monotherapy and in Combination With Endocrine and Targeted Therapy in Adults With Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
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.
Inclusion: 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: Uncontrolled infection or significant concurrent medical conditions; 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; Symptomatic visceral disease at risk of imminent life-threatening complications; Any condition that would interfere with study participation or evaluation of study results; Clinically significant cardiovascular disease or prolonged QT syndrome; Untreated, symptomatic, or unstable brain metastases; Pregnancy or breastfeeding; Participation in another interventional clinical study.