A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC
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: MT-303, MT-303 +Atezolizumab + Bevacizumab.
- Кому может быть актуально
- Состояния в реестре: Hepatocellular Carcinoma. 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
- Австралия, South Korea, Тайвань
- 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 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including Hepatocellular Carcinoma
Обзор
This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability and define the RP2D of MT-303 alone (Module 1) and in combination with Atezo/Bev (Module 2) in participants with advanced hepatocellular carcinoma expressing GPC3.
Подробное описание
Participants will be enrolled into one of two treatment modules:
* Module 1 (Monotherapy): Participants will receive MT-303. * Module 2 (Combination therapy): Participants will receive MT-303 in combination with atezolizumab + bevacizumab (Atezo/Bev).
In Module 1 (Monotherapy), participants will receive MT-303 across five dose-escalation cohorts and in Module 2 (Combination therapy), participants will receive MT-303 in combination with Atezo/Bev across five dose-escalation cohorts.
Additional cohorts in both modules may be scheduled based on emerging safety and PK data.
Participants will be sequentially enrolled into Cohorts 1 through 5. Both modules will be enrolled concurrently, with Module 2 dosing beginning at one dose level below the known safe dose in Module 1. Safety Review Committee decisions will be informed by all available safety data from Modules 1 and 2.
Вмешательства
- Препарат MT-303
MT-303 - Препарат MT-303 +Atezolizumab + Bevacizumab
MT-303 in combination with Atezo/Bev
Первичные конечные точки
- Type, incidence and severity of Adverse Events [Срок оценки: Up to 2 years from the last dose of Investigational Medicinal Product (IMP)]
- Recommended Phase 2 Dose (RP2D) [Срок оценки: 28 days from the last dose of IMP]
- Optimal Biological dose (OBD) [Срок оценки: 21 days from the last dose of IMP]
- Change from baseline in vital signs [Срок оценки: Up to 30 days from the last dose of IMP]
- Change in laboratory parameters [Срок оценки: Up to 30 days from the last dose of IMP]
- Change from baseline in ECG parameters [Срок оценки: Screening, Day 1 and Day 15]
Вторичные конечные точки (12)
- Pharmacokinetics (PK) [Срок оценки: Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.]
- Pharmacokinetics (PK) [Срок оценки: Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.]
- Pharmacokinetics (PK) [Срок оценки: Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.]
- Pharmacokinetics (PK) [Срок оценки: Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.]
- Pharmacokinetics (PK) [Срок оценки: Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.]
- Pharmacokinetics (PK) [Срок оценки: Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.]
- Pharmacokinetics (PK) [Срок оценки: Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.]
- To assess adverse events of special interest (AESI) by measuring infusion reaction [Срок оценки: upto 2 years from the last dose of IMP]
- To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS) [Срок оценки: Up to 2 years from the last dose of IMP]
- To assess adverse events of special interest (AESI) by measuring immune effector cell-associated neurotoxicity syndrome (ICANS) [Срок оценки: Up to 2 years from the last dose of IMP]
- To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction [Срок оценки: Up to 2 years from the last dose of IMP]
- To assess adverse events of special interest (AESI) by checking for second primary malignancy [Срок оценки: upto 2 years from the last dose of IMP]
Критерии участия
Критерии включения
- Aged 18 years or older
- Histological diagnosis of advanced/recurrent or metastatic and/or unresectable HCC. \[Note: participants with other tumor types expressing GPC3 may be eligible for Module 1 pending a discussion with the Medical Monitor. Only participants with HCC are eligible for Module 2.
- Measurable lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Child-Pugh score: Class A
- Adequate organ function
General Exclusion Criteria
- Known active CNS metastasis and/or carcinomatous meningitis.
- Any acute illness including active infection
- History of liver transplantation or on waiting list
- Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- History of symptomatic congestive heart failure
- History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.
Additional Module 2 Exclusion Criteria:
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Significant cardiovascular disease
- History of severe hypersensitivity to atezolizumab and/or bevacizumab.
- History of idiopathic pulmonary fibrosis
- Prior history of hypertensive crisis or hypertensive encephalopathy.
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
Австралия · 4 центра
- St Vincent's Hospital — Sydney
- Integrated Clinical Oncology Network (ICON) Pty Ltd — Woolloongabba
- The Alfred Hospital — Melbourne
- Linear Clinical Research — Murdoch
South Korea · 3 центра
- Pusan National Univesity Hospital — Busan
- Cha University Bundang Medical Center — Gyeonggi-do
- Seoul National University Hospital — Seoul
Тайвань · 2 центра
- National Taiwan University Hospital — Taipei
- Taipei Tzu Chi Hospital — Taipei
Идентификаторы
NCT: NCT06478693 · MTX-GPC3-303