Идёт набор NCT06638307
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: MEN2312, Elacestrant.
- Кому может быть актуально
- Состояния в реестре: Advanced Breast Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer
Обзор
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
Вмешательства
- Препарат MEN2312
MEN2312 administered as oral tablets. - Препарат Elacestrant
Elacestrant administered as oral tablets.
Первичные конечные точки
- Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312 [Срок оценки: Baseline through Day 28]
- Recommended Phase 2 Dose (RP2D) of MEN2312 [Срок оценки: Baseline through Month 6]
Вторичные конечные точки (10)
- Overall Response Rate (ORR) [Срок оценки: Baseline through 28 days after the last treatment administration (up to approximately 7 months)]
- Duration of Response (DOR) [Срок оценки: Baseline through 28 days after the last treatment administration (up to approximately 7 months)]
- Clinical Benefit Rate (CBR) [Срок оценки: Baseline through 28 days after the last treatment administration (up to approximately 7 months)]
- Progression-free Survival (PFS) [Срок оценки: Baseline through 28 days after the last treatment administration (up to approximately 7 months)]
- Overall Survival (OS) [Срок оценки: Baseline through 3 months after the last treatment administration (up to approximately 9 months)]
- Time to Response (TTR) [Срок оценки: Baseline through 28 days after the last treatment administration (up to approximately 7 months)]
- Area Under the Plasma Concentration-time Curve (AUC) of MEN2312 When Administered as Monotherapy [Срок оценки: Up to 6 months post dose]
- AUC of MEN2312 When Administered as Combination Therapy [Срок оценки: Up to 6 months post dose]
- Amount of MEN2312 Excreted in Urine When Administered as Monotherapy [Срок оценки: Up to 2 months post dose]
- Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy [Срок оценки: Up to 6 months post dose]
Критерии участия
Критерии включения
- Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
- Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.
- Participant must have received at least 1 prior line of endocrine therapy for advanced/metastatic disease or participant who has radiological evidence of breast cancer recurrence or progression during or within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants.
- Progression on previous cyclin-dependent kinase 4 and 6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.
Критерии исключения
- Active or newly diagnosed central nervous system metastases.
- Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement >50%.
- Participants with any toxicities related to prior radiation therapy that have not resolved to baseline or to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2).
Note: Other inclusion/exclusion criteria may apply.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 37 центров
- Highlands Oncology Group — Springdale
- City of Hope — Duarte
- UC San Diego Moores Cancer Center — La Jolla
- Stanford Cancer Center — Palo Alto
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
- UCLA Hematology Oncology - Parkside — Santa Monica
- Yale Comprehensive Cancer Center — New Haven
- Advent Health Orlando — Altamonte Springs
- … и ещё 29 центров
Испания · 8 центров
- Hospital Universitario Vall d'Hebron - Vall d'Hebron Institute of Oncology (VHIO) Medical — Barcelona
- IOB - Madrid Fundacion Hermanas Hospitalarias (Hospital Beata Maria Ana) — Madrid
- START Madrid - Hospital Universitario Fundacion Jimenez Diaz — Madrid
- Hospital Universitario 12 Octubre Servico de Oncologia Medica — Madrid
- START Madrid - Centro Integral Oncologico Clara Campal (CIOCC), Hospital HM Sanchinarro — Madrid
- Hospital Clinico San Carlos — Madrid
- Hospital Clinico Universitario De Valencia Oncologia Medica — Valencia
- Hospital Universitario y Politecnico La Fe Oncologia Medica — Valencia
Идентификаторы
NCT: NCT06638307 · MEN2312-01 · 2024-514661-19-00 · U1111-1308-5349