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Набира участници Фаза 1 NCT06478693

A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Hepatocellular Carcinoma

Спонсор: Myeloid Therapeutics

Налично на: БГ
Обобщение
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.
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.
Кой може да участва
Inclusion Criteria * 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.
Места на провеждане 3
Австралия (1)
St Vincent's Hospital
Sydney , New South Wales
Южна Корея (1)
Pusan National Univesity Hospital
Busan
Taiwan (1)
National Taiwan University Hospital
Taipei
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.07.2024
Крайна дата
31.05.2028
Регистрационен номер
NCT06478693
Източник
anzctr
Запитване за медицински туризъм

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