Prelude Therapeutics Incorporated
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.
This is a first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of PRT13722, a selective oral KAT6A protein degrader, in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer. The study will evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722 administered as monotherapy and in combination with fulvestrant, abemaciclib plus fulvestrant, or imlunestrant to determine recommended dose(s) for expansion and evaluate preliminary clinical activity. The…
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…
PRT13722 is an investigational oral drug administered once daily at the assigned dose level.
Fulvestrant is an approved selective estrogen receptor degrader (SERD) administered on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, then once monthly as an intramuscular injection into the buttocks (gluteal muscle).
Abemaciclib is an approved oral cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor administered twice daily and used in combination with endocrine therapy for HR-positive, HER2-negative breast cancer.
Imlunestrant is an approved oral SERD administered once daily.