Исследование повышения дозы и расширения дозы HM16390 при распространенных или метастатических солидных опухолях
Открытое многоцентровое исследование I фазы с повышением и расширением дозы HM16390 у пациентов с распространенными или метастатическими солидными опухолями
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent and in combination with pembrolizumab to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors.
Dose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the RDEs to be tested in the Dose-Expansion Part are determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent and in combination with pembrolizumab when administered at the RDEs to subjects in indication-specific expansion cohorts.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 1
Контакты и местонахождение
Контакты исследования
- Имя: Hyebin Son
- Номер телефона: 82-2-410-9835
- Электронная почта: hyebin.son@hanmi.co.kr
Места учебы
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California
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Los Angeles, California, Соединенные Штаты, 90095
- Рекрутинг
- The Regents of the University of California on behalf of its Los Angeles campus
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02114
- Рекрутинг
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Соединенные Штаты, 48201
- Рекрутинг
- Karmanos Cancer Institute
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Seoul, Южная Корея, 03080
- Рекрутинг
- Seoul National University Hospital
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Seoul, Южная Корея, 06351
- Рекрутинг
- Samsung Medical Center
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Seoul, Южная Корея, 03722
- Рекрутинг
- Severance Hospital
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Seoul, Южная Корея, 05505
- Активный, не рекрутирующий
- Asan Medical Center
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Южная Корея, 13620
- Рекрутинг
- Seoul National University Bundang Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Key Inclusion Criteria:
- Have a histologically and/or cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit.
- Patients in the Dose-Escalation Part must have evaluable or measurable disease at baseline and the patients for Dose-Ranging and Dose-Expansion Part must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before allocation or randomization.
- Age of 18 years or older (or country's legal age of majority if the legal age was >18 years)
- Adequate renal function.
- Adequate hematologic function.
- Adequate liver function.
Key Exclusion Criteria:
- Received prior treatment with agent targeting the IL-2, IL-7, or IL-15 receptors, or related to mode of action of HM16390.
- Known active CNS metastases and/or carcinomatous meningitis.
- History of severe toxicities associated with a prior immunotherapy.
- Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per NCI-CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
- Has ongoing or suspected autoimmune disease.
- Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.
- History of chronic liver disease or evidence of hepatic cirrhosis.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: HM16390
HM16390 Monotherapy |
HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle |
|
Экспериментальный: HM16390 + pembrolizumab
HM16390 in combination with pembrolizumab |
Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
Другие имена:
HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence and nature of DLTs
Временное ограничение: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
|
To evaluate safety and tolerability of HM16390 as a single agent and in combination with pembrolizumab |
At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
|
|
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Временное ограничение: Throughout the study until end of safety follow-up period (90 days after the last treatment)
|
To evaluate safety and tolerability of HM16390 as a single agent, and in combination with pembrolizumab |
Throughout the study until end of safety follow-up period (90 days after the last treatment)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Objective response rate (ORR)
Временное ограничение: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
|
Disease Control Rate (DCR)
Временное ограничение: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
DCR will be measured as the proportion of subject with confirmed CR, PR, or Stable Disease (SD) as per RECIST v1.1 |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
|
The maximum serum concentration (Cmax)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The time to reach Cmax (Tmax)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The AUC extrapolated to infinity (AUCinf)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The AUC during the dosing interval (AUCtau)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The serum concentration at the end of the dosing interval (Ctrough)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The elimination half-life (T1/2)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The apparent volume of distribution (Vd/F)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The apparent clearance (CL/F)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
Progression-free survival (PFS)
Временное ограничение: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v1.1 or until death from any cause, whichever occurs first |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
|
Duration of response (DOR)
Временное ограничение: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v1.1 or death from any cause, whichever occurs first. |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
Соавторы и исследователи
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HM-LIL2-101
- KEYNOTE-G39 (Другой идентификатор: Merck & Sharp Dohme LLC)
- MK-3475-G39 (Другой идентификатор: Merck & Sharp Dohme LLC)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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