NCT07905001Not yet recruitingPhase 1
A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 242 (estimated)
- First submitted
- 15 Oct 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Prelude Therapeutics Incorporated
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07905001
- EU CT number
- 2026-527825-37-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 242
- From 30 Oct 2026 to the primary completion date, 31 Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Symptomatic visceral disease at risk of imminent life-threatening complications
- Any condition that would interfere with study participation or evaluation of study results
Lab values
- Clinically significant cardiovascular disease or prolonged QT syndrome
Other
- Untreated, symptomatic, or unstable brain metastases
- Pregnancy or breastfeeding
- Participation in another interventional clinical study
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.