Исследование повышения дозы и расширения количества BH3120 при распространенных или метастатических солидных опухолях
Фаза I, открытое, многонациональное, многоцентровое исследование повышения и расширения дозы BH3120 у пациентов с распространенными или метастатическими солидными опухолями
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, 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 RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD 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: Hyunmin (Dan) Lee
- Номер телефона: 82-2-410-0470
- Электронная почта: Hyunmin.lee0607@hanmi.co.kr
Места учебы
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Florida
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Tampa, Florida, Соединенные Штаты, 33612
- Рекрутинг
- Moffitt Cancer Center
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Michigan
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Grand Rapids, Michigan, Соединенные Штаты, 49546
- Рекрутинг
- The START Center for Cancer Care - Midwest
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45219
- Рекрутинг
- Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
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Texas
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Dallas, Texas, Соединенные Штаты, 75230
- Отозван
- Mary Crowley Cancer Research
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San Antonio, Texas, Соединенные Штаты, 78229
- Рекрутинг
- Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
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Seoul, Южная Корея, 05505
- Рекрутинг
- Asan Medical Center
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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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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 or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.
- PD-L1 positive expression (Tumor Proportion Score ≥1% or Combined Positive Score ≥1).
- Have at least one lesion, not previously irradiated that can be accurately measured per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age of 18 years or older (or country's legal age of majority if the legal age was >18 years)
- Adequate Hematologic and liver function.
Key Exclusion Criteria:
- Has received prior therapy with an anti-4-1BB(CD137) agent.
- Known active CNS metastases and/or carcinomatous meningitis.
- Known additional malignancy that is progressing or has required active treatment.
- History of chronic liver disease or evidence of hepatic cirrhosis.
- History of severe toxicities associated with prior immunotherapy, except for adequately controlled endocrine-related adverse events managed with hormone replacement therapy.
- 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.
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: BH3120
Arm A: BH3120 Monotherapy |
BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle |
|
Экспериментальный: BH3120 + pembrolizumab
Arm B: BH3120 in combination with pembrolizumab |
BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle 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:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
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 BH3120 as a single agent and in combination with pembrolizumab administration |
Throughout the study until end of safety follow-up period (90 days after the last treatment)
|
|
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 BH3120 as a single agent and in combination with pembrolizumab administration |
At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The maximum serum concentration (Cmax)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon BH3120 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 BH3120 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 BH3120 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
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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 BH3120 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 BH3120 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The terminal half-life (T1/2)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon BH3120 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
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The apparent clearance (CL/F)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon BH3120 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
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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 BH3120 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
Frequency of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Временное ограничение: Throughout the study until treatment discontinuation (up to 2-3 years)
|
Immunogenicity of BH3120 |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
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)
|
|
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 v. 1.1 or death from any cause, whichever occurs first. |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
|
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 v.1.1 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)
|
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
- BH-BAFP-101
- KEYNOTE-F89 (Другой идентификатор: Merck Sharp & Dohme LLC)
- MK3475-F89 (Другой идентификатор: Merck Sharp & Dohme LLC)
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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