Идёт набор NCT07247110
A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
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: MK-4716, Pembrolizumab, Cetuximab.
- Кому может быть актуально
- Состояния в реестре: Malignant Neoplasm. 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, Австралия, Канада, Чили, Израиль +2
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of MK-4716 as Monotherapy and as Part of Combination Therapy in Participants With KRAS-Altered Advanced or Metastatic Solid Tumors
Обзор
Researchers are looking for new ways to treat certain advanced or metastatic solid tumors. The goal of this study is to learn about the safety of MK-4716 and if people tolerate it when taken alone or with other treatments.
Вмешательства
- Препарат MK-4716
Oral administration - Биопрепарат Pembrolizumab
Intravenous administration - Биопрепарат Cetuximab
Intravenous administration
Первичные конечные точки
- Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT) [Срок оценки: Up to approximately 28 days]
- Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 4 years]
- Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 4 years]
Вторичные конечные точки (4)
- Area Under the Concentration-Time Curve (AUC) of MK-4716 [Срок оценки: At designated timepoints (up to approximately 58 days)]
- Maximum Plasma Concentration (Cmax) of MK-4716 [Срок оценки: At designated timepoints (up to approximately 58 days)]
- Trough Plasma Concentration (Ctrough) of MK-4716 [Срок оценки: At designated timepoints (up to approximately 19 months)]
- Half-Life (t1/2) of MK-4716 [Срок оценки: At designated timepoints (up to approximately 58 days)]
Критерии участия
Критерии включения
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has received at least 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease
- Arm MK-4716 + Pembrolizumab: Has a confirmed diagnosis of metastatic non-small cell lung cancer
- Arm MK-4716 + Pembrolizumab: Must demonstrate presence of KRAS alteration
- Arm MK-4716 + Pembrolizumab: Must be untreated
- Has measurable disease
- Has the ability to swallow and retain oral medication
Критерии исключения
- Arm MK-4716 + Pembrolizumab: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Arm MK-4716 + Pembrolizumab: Has received any prior immunotherapy and was discontinued from that treatment
- Arm MK-4716 + Pembrolizumab: Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- History of human immunodeficiency virus infection
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has a known active central nervous system metastases and/or carcinomatous meningitis
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has Hepatitis B or Hepatitis C virus infection
- History of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
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
Австралия · 4 центра
- Blacktown Hospital ( Site 0455) — Sydney
- Monash Health ( Site 0452) — Clayton
- The Alfred Hospital ( Site 0453) — Melbourne
- One Clinical Research ( Site 0454) — Nedlands
США · 3 центра
- Rutgers Cancer Institute of New Jersey ( Site 0052) — New Brunswick
- NEXT Oncology ( Site 0051) — Irving
- NEXT Virginia ( Site 0054) — Fairfax
Израиль · 3 центра
- Rambam Health Care Campus ( Site 0252) — Haifa
- Rabin Medical Center ( Site 0253) — Petah Tikva
- Sheba Medical Center ( Site 0251) — Ramat Gan
Испания · 3 центра
- Hospital General Universitari Vall d Hebron ( Site 0360) — Barcelona
- Hospital Clinic de Barcelona ( Site 0362) — Barcelona
- Hospital Universitario Fundacion Jimenez Diaz ( Site 0361) — Madrid
Канада · 2 центра
- Princess Margaret Cancer Centre ( Site 0001) — Toronto
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésu — Québec
Чили · 2 центра
- Pontificia Universidad Catolica de Chile-CICUC ( Site 0103) — Santiago
- Bradfordhill ( Site 0102) — Santiago
South Korea · 2 центра
- Seoul National University Hospital ( Site 0501) — Seoul
- Asan Medical Center ( Site 0502) — Seoul
Идентификаторы
NCT: NCT07247110 · 4716-001 · 2025-522495-84 · U1111-1323-3663 · MK-4701-001