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Набира участници Фаза 1 NCT07403721

AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)

Спонсор: Amgen

Налично на: БГ
Обобщение
The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H/dMMR solid tumors.
Кой може да участва
Inclusion Criteria: * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years). * Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing. * Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block must be available. Participants without archived tumor tissue may enroll by undergoing tumor biopsy before dosing. * Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). * Eastern Cooperative Oncology Group performance (ECOG) 0-1. * Adequate organ function as defined in the protocol. Exclusion Criteria: * Participants with primary central nervous system (CNS) tumors. * Impaired cardiac function or clinically significant cardiac disease. * Major surgery within 28 days of trial day 1. * Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 21 days of first dose of trial treatment, unless anti-tumor therapy is a therapy with 5 times the half-life being shorter than 21 days (in this case, enrollment may be allowed with washout from prior therapy of \< 21 days. * Radiation therapy within 28 days of the first dose of trial treatment (or local or focal radiotherapy with palliative intent within 14 days of the first dose). * Gastrointestinal tract disease causing the inability to take per os (PO) medication, malabsorption syndrome, requirement for intravenous (IV) alimentation, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
Интервенции
AMG 436
DRUG
Места на провеждане 6
Австралия (1)
Peter MacCallum Cancer Centre
Melbourne , Victoria
Китай (1)
Zhongshan Hospital Fudan University
Shanghai , Shanghai Municipality
Япония (3)
National Cancer Center Hospital
Chuo-ku , Tokyo
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku , Tokyo
Aichi Cancer Center
Nagoya , Aichi-ken
САЩ (1)
Next Oncology - Dallas
Irving , Texas
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
99 Years
Здрави доброволци
Не
Начална дата
08.04.2026
Крайна дата
28.06.2028
Регистрационен номер
NCT07403721
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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