Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer

Официальное название

Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer

Обзор

The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.

Подробное описание

The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.

Вмешательства

• Препарат Serabelisib
  Serabelisib is a selective, small molecule inhibitor of PI3Kα.
• Препарат Sapanisertib
  Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.
• Препарат Fulvestrant
  Fulvestrant is a first-in-class SERD.

Первичные конечные точки

• Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs) [Срок оценки: 2 years]

Вторичные конечные точки (6)

• Objective Response Rate (ORR) [Срок оценки: Up to 2 years.]
• Progression Free Survival (PFS) [Срок оценки: Up to 5 years.]
• Progression Free Survival (PFS) at 6 months [Срок оценки: 6 months]
• Overall Survival (OS) [Срок оценки: Up to 5 years.]
• Clinical Benefit Rate (CBR) [Срок оценки: Up to 5 years.]
• Duration of Response (DoR) [Срок оценки: Up to 5 years.]

Критерии участия

Критерии включения

• Histologically confirmed diagnosis of HR+/HER2- breast cancer.
• Documented evidence of advanced or recurrent disease that is not amenable to surgery/radiation for curative intent.
• Participant has received at least one prior systemic therapy.
• At least 1 measurable or evaluable target lesion according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.
• Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.

Критерии исключения

• Participants with triple-negative breast cancer.
• Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.
• Active malignancy (except for breast cancer, definitively treated in-situ carcinomas \[e.g., breast, cervix, bladder\], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.
• Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.
• Significant cardiovascular impairment.
• Active, uncontrolled infection.
• Concurrent participation in another therapeutic clinical trial.
• Prior radiation therapy within 21 days prior to start of study treatment.
• Participants who have received a prior PI3K, AKT, mTORC1/2, or dual PI3K/mTOR inhibitor.
• Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study.
• Prolongation of QTc interval to >480 ms.
• Type 1 or Type 2 diabetes mellitus on insulin.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• START Los Angeles — Los Angeles
• Rocky Mountain Cancer Centers — Lone Tree
• Oncology Associates of Oregon — Springfield
• SCRI Oncology Partners — Nashville
• Texas Oncology - Central/South — Austin
• START San Antonio — San Antonio
• Texas Oncology - San Aantonio — San Antonio

Идентификаторы

NCT: NCT07558733 · FTH-PIK-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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