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

5. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

242

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Ohio
      • Maumee, Ohio, Vereinigte Staaten, 43537
        • Rekrutierung
        • Taylor Cancer Research Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: PRT13722

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

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

Arzneimittel: 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).
Experimental: 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.
Arzneimittel: PRT13722

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

Arzneimittel: 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).

Arzneimittel: 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.
Experimental: 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.
Arzneimittel: PRT13722

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

Arzneimittel: Imlunestrant

Imlunestrant is an approved oral SERD administered once daily.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Dose limiting toxicity of PRT13722 (Parts 1A and 2)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Preliminary Antitumor Activity: Objective Response Rate (Parts 1A and 2)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Prelude Therapeutics Incorporated

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

16. November 2026

Primärer Abschluss (Geschätzt)

31. Oktober 2028

Studienabschluss (Geschätzt)

31. Oktober 2029

Studienanmeldedaten

Zuerst eingereicht

15. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Oktober 2026

Zuerst gepostet (Tatsächlich)

29. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. November 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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