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Life sciences · Phase 1 Trial
ClinicalTrials.gov · November 9, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07905001). This is a study registration, not published results. Lead sponsor: Prelude Therapeutics Incorporated. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 242 participants (ESTIMATED). Conditions: Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, HR-positive Breast Cancer, HR+/HER2- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer. Interventions: DRUG: PRT13722; DRUG: Fulvestrant; DRUG: Abemaciclib; DRUG: Imlunestrant. Primary outcome measures: Dose limiting toxicity of PRT13722 (Parts 1A and 2) , Through cycle 1 (28 days); Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of PRT13722 as monotherapy and in combination (Parts 1A and 2) , Through study completion, an average of 2 years; Preliminary Antitumor Activity: Objective Response Rate (Parts 1B and 3) , Through study completion, an average of 2 years. Brief summary: 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.