Меню
Идёт набор NCT05259709

A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab

Фаза I С лечением Advanced Solid Tumor Metastatic Solid Tumor

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: 89Zr˗DFO˗REGN5054, cemiplimab.
Кому может быть актуально
Состояния в реестре: Advanced Solid Tumor, Metastatic Solid Tumor. 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab

Обзор

This study is researching an experimental drug called 89Zr-DFO-REGN5054 and cemiplimab. The study is focused on patients with a type of cancer that can be potentially imaged using 89Zr-DFO-REGN5054 and show special tumor features that may be important to the way the immune system fights cancer. The aim of the study is to study the safety and tolerability (how the body reacts to the drug) of the imaging agent 89Zr-DFO REGN5054. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)

Вмешательства

  • Препарат 89Zr˗DFO˗REGN5054
    Administered by intravenous (IV) infusion during Part A and B.
  • Препарат cemiplimab
    Administered by IV infusion every 3 weeks (Q3W).

Первичные конечные точки

  • Incidence and severity of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to day 8, after the infusion of 89Zr˗DFO˗REGN5054]
  • Incidence and severity of TEAEs [Срок оценки: Up to approximately week 115]
Вторичные конечные точки (9)
  • Clinical dosimetry based on tissue radiation absorbed dose calculated from positron emission tomography (PET) image acquisition data [Срок оценки: On days 1, 5 and 8]
  • Clinical dosimetry based on tissue radiation effective dose calculated from PET image acquisition data [Срок оценки: On days 1, 5 and 8]
  • Concentration of 89Zr-DFO-REGN5054 in serum [Срок оценки: On days 1, 5 and 8]
  • Serum imaging agent activity concentration of area under the curve (AUC0-7) [Срок оценки: Up to day 8]
  • 89Zr-DFO-REGN5054 uptake across cluster of differentiation 8 (CD8)-expressing normal tissues and tumors [Срок оценки: At the time of imaging, up to day 8]
  • Blood pool uptake of 89Zr-DFO-REGN5054 with subsequent calculation of standardized uptake value (SUV) tumor-to-blood ratios [Срок оценки: At the time of imaging, up to day 8]
  • Association of 89Zr˗DFO˗REGN5054 autoradiographic signal intensity distribution with CD8 expression in tumor tissues [Срок оценки: At Baseline]
  • Association of 89Zr-DFO-REGN5054 uptake with CD8 expression in tumor tissues [Срок оценки: At Baseline]
  • Association of tumor-to-blood ratio of 89Zr-DFO-REGN5054 with CD8 expression in tumor tissues [Срок оценки: At Baseline]

Критерии участия

Критерии включения

  • Advanced or metastatic solid tumors that may respond to anti-programmed cell death 1 (PD-1) immunotherapy
  • Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  • Adequate organ and bone marrow function as defined in the protocol
  • Willing and able to comply with clinic visits and study-related procedures (including required tumor biopsy for Part B)

Критерии исключения

  • Currently receiving another cancer treatment or inadequate time since last therapy, as defined in the protocol
  • Has not yet recovered from acute toxicities from prior therapy; exceptions defined in the protocol
  • Prior treatment with a blocker of the PD-1/Programmed death ligand 1 (PD-L1) pathway
  • Currently receiving or has received chimeric antigen receptor (CAR-T) cell therapy
  • Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression
  • Known history of or any evidence of interstitial lung disease, active, noninfectious pneumonitis (past 5 years) or active tuberculosis

NOTE: Other protocol defined inclusion/exclusion criteria apply.

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

Нидерланды · 1 центр
  • UMC Groningen — Groningen

Идентификаторы

NCT: NCT05259709 · R5054-ONC-1843 · 2019-001604-38 · 2024-515351-37-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗