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

5 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

242

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Ohio
      • Maumee, Ohio, États-Unis, 43537
        • Recrutement
        • Taylor Cancer Research Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: PRT13722

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

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

Médicament: 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).
Expérimental: 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.
Médicament: PRT13722

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

Médicament: 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).

Médicament: 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.
Expérimental: 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.
Médicament: PRT13722

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

Médicament: Imlunestrant

Imlunestrant is an approved oral SERD administered once daily.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Dose limiting toxicity of PRT13722 (Parts 1A and 2)
Délai: 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)
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Preliminary Antitumor Activity: Objective Response Rate (Parts 1A and 2)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Prelude Therapeutics Incorporated

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

16 novembre 2026

Achèvement primaire (Estimé)

31 octobre 2028

Achèvement de l'étude (Estimé)

31 octobre 2029

Dates d'inscription aux études

Première soumission

15 octobre 2026

Première soumission répondant aux critères de contrôle qualité

23 octobre 2026

Première publication (Réel)

29 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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