SB17170 Phase 1 Clinical Trial in Solid Tumors
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: SB17170.
- Кому может быть актуально
- Состояния в реестре: Solid Tumor. Базовые параметры: от 19 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
- South Korea
- 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
An Open-label, Multicenter, Phase 1 Clinical Trial to Evaluate MTD, Safety, PK/PD and Preliminary Anti-tumor Activity of SB17170 in Patients With Locally Advanced or Metastatic Solid Tumors Who Have Failed Standard of Care
Обзор
Phase 1 Open-label, multicenter, dose escalation, dose expansion study
Подробное описание
This is an open-label, multicenter, Phase 1 clinical trial to evaluate the maximum tolerated dose, safety, pharmacokinetic/pharmacodynamic characteristics and preliminary anti-tumor activity of SB17170 when administered alone(1a) and co-administered with standard of care(1b) to patients with locally advanced or metastatic solid tumors who have failed standard of care.
1 cycle of treatment of this clinical trial is 21 days, and tumors are assessed every 2 cycles.
Вмешательства
- Препарат SB17170
SB17170 capsules, Oral administration 21days/cycle
Первичные конечные точки
- Safety and tolerability of SB17170 [Срок оценки: At the end of Cycle 1 (each cycle is 21 days)]
Вторичные конечные точки (12)
- Pharmacokinetic(Cmax) [Срок оценки: At Day1 and D21 of Cycle 1 (each cycle is 21 days)]
- Pharmacokinetic(Tmax) [Срок оценки: At Day1 and D21 of Cycle 1 (each cycle is 21 days)]
- Pharmacokinetic(AUC) [Срок оценки: At Day1 and D21 of Cycle 1 (each cycle is 21 days)]
- The anti-tumor activity with RECIST v1.1 [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 100weeks]
- Pharmacodynamics(TIL) [Срок оценки: At Day1 and D22 of Cycle 1 (each cycle is 21 days)]
- Pharmacodynamics(TAM) [Срок оценки: At Day1 and D21 of Cycle 1 (each cycle is 21 days)]
- Pharmacodynamics(T cell activation) [Срок оценки: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)]
- Pharmacodynamics(PD-L1) [Срок оценки: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)]
- Pharmacodynamics(High Mobility Group Box 1 ) [Срок оценки: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)]
- Pharmacodynamics(S100A8) [Срок оценки: At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days)]
- Pharmacodynamics(S100A9) [Срок оценки: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)]
- Pharmacodynamics(CXCL8) [Срок оценки: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)]
Критерии участия
Критерии включения
- A patient with a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors.
- A person who has failed the known standard of care or has developed resistance to the standard of care and no longer has applicable standard of care
- A patient with at least one measurable lesion according to the RECIST v1.1 criteria.
- A person with Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
- Those with an expected survival period of 3 months or more at the discretion of of the investigator.
Критерии исключения
- A patient who has received drugs targeting High Mobility Group Box 1 (HMGB1).
- A patient who has received or is undergoing chemotherapy (including chemotherapy, radiation therapy, immunotherapy, hormone therapy, targeted therapy, biological products, and tumor embolization) within 28 days from the first administration date of the investigational drug.
- A person who needs to take contraindicated drugs or is expected to take them during the study period.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
South Korea · 3 центра
- Asan Medical Center — Seoul
- Seoul National University Hospital — Seoul
- Severance Hospital — Seoul
Идентификаторы
NCT: NCT05522868 · SMARTT-001