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A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer

5. listopadu 2026 aktualizováno: Prelude Therapeutics Incorporated

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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 study is conducted in three parts:

Part 1: Monotherapy dose escalation and backfill cohorts. Part 2: Combination dose-escalation cohorts with fulvestrant, abemaciclib plus fulvestrant, and imlunestrant.

Part 3: Combination dose-expansion cohorts to further evaluate safety and preliminary efficacy at the selected dose levels.

Up to approximately 240 participants are planned for enrollment across the three parts of the study.

Typ studie

Intervenční

Zápis (Odhadovaný)

242

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Ohio
      • Maumee, Ohio, Spojené státy, 43537
        • Nábor
        • Taylor Cancer Research Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: PRT13722 Monotherapy

Participants receive PRT13722 once daily as monotherapy. This arm includes dose-escalation (Part 1A) and backfill cohorts (Part 1B) evaluating PRT13722 in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer to support the selection of RDE.
Lék: PRT13722

PRT13722 is an investigational oral drug administered once daily at the assigned dose level.
Experimentální: PRT13722 + Fulvestrant

Participants receive PRT13722 once daily in combination with fulvestrant. This study includes a dose-escalation (Part 2A) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3A) at the RDE.
Lék: PRT13722

PRT13722 is an investigational oral drug administered once daily at the assigned dose level.

Lék: Fulvestrant

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).
Experimentální: PRT13722 + Abemaciclib + Fulvestrant

Participants receive PRT13722 once daily in combination with abemaciclib and fulvestrant. This study includes a dose-escalation (Part 2B) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3B) at the RDE.
Lék: PRT13722

PRT13722 is an investigational oral drug administered once daily at the assigned dose level.

Lék: Fulvestrant

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).

Lék: Abemaciclib

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.
Experimentální: PRT13722 + Imlunestrant

Participants receive PRT13722 once daily in combination with imlunestrant. This study includes a dose-escalation (Part 2C) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3C) at the RDE.
Lék: PRT13722

PRT13722 is an investigational oral drug administered once daily at the assigned dose level.

Lék: Imlunestrant

Imlunestrant is an approved oral SERD administered once daily.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Dose limiting toxicity of PRT13722 (Parts 1A and 2)
Časové okno: Through cycle 1 (28 days)

Incidence of dose limiting toxicities, defined according to protocol-specified criteria
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)
Časové okno: Through study completion, an average of 2 years

Safety and tolerability assessed by the number of participants with treatment-emergent adverse events, serious adverse events, adverse events leading to dose modification, treatment interruption, or treatment discontinuation, and clinically significant laboratory abnormalities. Adverse events and selected laboratory abnormalities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0
Through study completion, an average of 2 years
Preliminary Antitumor Activity: Objective Response Rate (Parts 1B and 3)
Časové okno: Through study completion, an average of 2 years

Proportion of patients with best overall response of either complete response or partial response, as assessed by the investigator per RECIST v1.1
Through study completion, an average of 2 years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Preliminary Antitumor Activity: Objective Response Rate (Parts 1A and 2)
Časové okno: Through study completion, an average of 2 years

Proportion of patients with best overall response of either complete response or partial response, as assessed by the investigator per RECIST v1.1
Through study completion, an average of 2 years
Duration of Response
Časové okno: Through study completion, an average of 2 years

Time from first documented response to disease progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first.
Through study completion, an average of 2 years
Clinical Benefit Response
Časové okno: Through study completion, an average of 2 years

Proportion of patients with a best overall response of complete response, partial response, or durable stable disease (24 weeks or longer), as assessed by the investigator per RECIST v1.1
Through study completion, an average of 2 years
Progression-Free Survival
Časové okno: Through study completion, an average of 2 years

Time from the date of first dose of investigational product to the date of first documented disease progression, as assessed by the investigator per RECIST v1.1, or death due to any cause
Through study completion, an average of 2 years
Overall Survival
Časové okno: Through study completion, an average of 2 years

Time from the date of first dose of investigational product to death due to any cause
Through study completion, an average of 2 years
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] of PRT13722 as Monotherapy and in Combination (Parts 1B and 3)
Časové okno: Through study completion, an average of 2 years

Safety and tolerability will be evaluated by incidence of adverse events leading to dose modifications, treatment interruptions, treatment discontinuations, and clinically significant laboratory abnormalities graded according to NCI CTCAE, Version 6.0
Through study completion, an average of 2 years
Maximum Observed Plasma Concentration (Cmax)
Časové okno: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)

Maximum observed plasma concentration will be calculated using non-compartmental analysis
Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Time To Maximum Concentration (Tmax)
Časové okno: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)

Time to maximum concentration will be calculated using non-compartmental analysis
Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Terminal Elimination Half-life (T1/2)
Časové okno: Cycle 1 Day 1 (each cycle is 28 days)

Terminal elimination half-life will be calculated using non-compartmental analysis
Cycle 1 Day 1 (each cycle is 28 days)
Area under the plasma concentration versus time curve (AUC)
Časové okno: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)

Area under the plasma concentration-time curve will be calculated using non-compartmental analysis
Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Steady State Trough Concentrations
Časové okno: Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)

Steady state trough concentrations will be calculated using non-compartmental analysis
Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Prelude Therapeutics Incorporated

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

16. listopadu 2026

Primární dokončení (Odhadovaný)

31. října 2028

Dokončení studie (Odhadovaný)

31. října 2029

Termíny zápisu do studia

První předloženo

15. října 2026

První předloženo, které splnilo kritéria kontroly kvality

23. října 2026

První zveřejněno (Aktuální)

29. října 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. listopadu 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PRT13722-01
  • 2026-527825-37-00 (Ctis)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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