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

5 de novembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

242

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Ohio
      • Maumee, Ohio, Estados Unidos, 43537
        • Recrutamento
        • Taylor Cancer Research Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: 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.
Medicamento: PRT13722

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

Medicamento: 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.
Medicamento: PRT13722

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

Medicamento: 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).

Medicamento: 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.
Medicamento: PRT13722

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

Medicamento: Imlunestrant

Imlunestrant is an approved oral SERD administered once daily.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Dose limiting toxicity of PRT13722 (Parts 1A and 2)
Prazo: 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)
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Preliminary Antitumor Activity: Objective Response Rate (Parts 1A and 2)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Prelude Therapeutics Incorporated

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

16 de novembro de 2026

Conclusão Primária (Estimado)

31 de outubro de 2028

Conclusão do estudo (Estimado)

31 de outubro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

15 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de outubro de 2026

Primeira postagem (Real)

29 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de novembro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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