Идёт набор NCT07030959

Study of AUBE00 in Patients With Solid Tumors

Фаза I С лечением 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: AUBE00, Cetuximab.
Кому может быть актуально: Состояния в реестре: Solid Tumors. 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, Япония
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 I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors

Обзор

This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity of AUBE00 in patients with locally advanced or metastatic solid tumors.The total number of patients in this study will be approximately 90 to 130.

Вмешательства

Препарат AUBE00
AUBE00 as an oral administration
Препарат Cetuximab
Cetuximab as an IV infusion

Первичные конечные точки

Adverse events of AUBE00 [Part A, B, C] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]
Number of participants with changes in vital signs of AUBE00 [Part A, B, C] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]
Number of participants with changes in clinical laboratory test of AUBE00 [Part A, B, C] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]
Number of participants with changes in Electrocardiograms (ECGs) of AUBE00 [Part A, B, C] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]
Maximum tolerated dose (MTD) of AUBE00 [Part A, C] [Срок оценки: From Cycle 0 Day 1 until Cycle 2 Day 1 (approximately 30 days) (Cycle 0: 6 to 9 days, Cycle 1 and beyond each Cycle: 21 days) [Part A]; From Cycle 1 Day 1 until Cycle 2 Day 1 (approximately 28 days) (Cycle 1 and beyond each Cycle: 28 days) [Part C]]
Time to reach maximum plasma concentration (Tmax) of AUBE00 [Part A] [Срок оценки: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)]
Maximum plasma concentration (Cmax) of AUBE00 [Part A] [Срок оценки: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)]
Elimination half-life (t1/2) of AUBE00 [Part A] [Срок оценки: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)]
Area under the plasma concentration-time curve (AUC) of AUBE00 [Part A] [Срок оценки: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)]
Objective response of AUBE00 [Part B, C] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]

Вторичные конечные точки (12)

Objective response of AUBE00 [Part A] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]
Disease control of AUBE00 [Part A, B, C] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]
Duration of response (DoR) of AUBE00 [Part A, B, C] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]
Progression free survival (PFS) of AUBE00 [Part A, B, C] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]
Anti-AUBE00 antibodies of AUBE00 [Part A, B, C] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]
Overall survival (OS) of AUBE00 [Part B, C] [Срок оценки: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)]
Time to reach maximum plasma concentration (Tmax) of AUBE00 [Part B, C] [Срок оценки: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].]
Maximum plasma concentration (Cmax) of AUBE00 [Part B, C] [Срок оценки: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].]
Elimination half-life (t1/2) of AUBE00 [Part B, C] [Срок оценки: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)[Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].]
Area under the plasma concentration-time curve (AUC) of AUBE00 [Part B, C] [Срок оценки: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)[Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].]
Time to reach maximum serum concentration (Tmax) of cetuximab [Part C] [Срок оценки: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].]
Maximum serum concentration (Cmax) of cetuximab [Part C] [Срок оценки: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].]

Критерии участия

Критерии включения

Age ≥ 18 years at time of signing Informed Consent Form (ICF)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients with Kirsten rat sarcoma (KRAS) alteration confirmed by local tests or central laboratory test (Details are defined for each part)
Refractory or resistant to standard therapies or standard therapies are not available

Критерии исключения

Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study or within 27 weeks after the last dose of AUBE00 or within 2 months after the last dose of cetuximab, whichever is longer.
Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)
Significant cardiovascular disease, such as New York Heart Association (NYHA) Class II or greater cardiac disease, unstable angina, or myocardial infraction within the previous 6 months or unstable arrhythmias within the previous 3 months
Patient with complications from a cerebrovascular disorder (such as subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, etc.) or a history of such complications within 6 months prior to enrollment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет