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Набира участници Фаза 1 NCT07247110

A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Malignant Neoplasm

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Места на провеждане 6
Австралия (1)
Blacktown Hospital ( Site 0455)
Sydney , New South Wales
Study Coordinator
Chile (1)
Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)
Santiago , Region M. de Santiago
Study Coordinator
Израел (1)
Rambam Health Care Campus ( Site 0252)
Haifa
Study Coordinator
Южна Корея (1)
Seoul National University Hospital ( Site 0501)
Seoul
Study Coordinator
Испания (1)
Hospital General Universitari Vall d Hebron ( Site 0360)
Barcelona
Study Coordinator
САЩ (1)
Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick , New Jersey
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
16.12.2025
Крайна дата
01.12.2030
Регистрационен номер
NCT07247110
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.