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Идёт набор NCT07690189

Study of NTB-928 in R/R OC

Фаза I С лечением Relapsed/Refractory Ovarian Carcinoma

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: NTB-928.
Кому может быть актуально
Состояния в реестре: Relapsed/Refractory Ovarian Carcinoma. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
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 Multicenter, Open-Label, Dose-Escalation and Expansion Study of NTB-928, a FRα-Targeting Bispecific T Cell Engager, in Subjects With Relapsed/Refractory Ovarian Carcinoma

Обзор

The goal of this clinical trial is to determine if NTB-928 can be given safely to adult females with ovarian cancer that has come back (relapsed) or stopped responding to treatment (refractory), how NTB-928 moves through the body, and how the immune system reacts to it. The study will also look for early signs of anti-cancer activity of NTB-928. The main questions the study aims to answer are: * What side effects do participants experience when receiving NTB-928, including side effects that limit how much of it can be safely given? * How is NTB-928 processed by the body at different dose levels? * Does the immune system react to NTB-928 during treatment? * What dose of NTB-928 can be given safely that shows early signs of activity against ovarian cancer?

Вмешательства

  • Препарат NTB-928
    NTB-928 is an investigational study drug administered as an intravenous infusion.

Первичные конечные точки

  • Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928 [Срок оценки: Up to 35 days]
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs), by severity and relatedness to NTB-928 [Срок оценки: Up to approximately 3 years]
  • Maximum plasma concentration (Cmax) [Срок оценки: Up to approximately 3 years]
  • Time to Cmax (Tmax) [Срок оценки: Up to approximately 3 years]
  • Area under the plasma concentration-time curve (AUC) over the dosing interval (AUC0-T) [Срок оценки: Up to approximately 3 years]
  • AUC from time zero to time t (AUC0-t) [Срок оценки: Up to approximately 3 years]
  • AUC from time 0 extrapolated to infinity (AUC0-∞) [Срок оценки: Up to approximately 3 years]
  • Terminal elimination half-life (t½) [Срок оценки: Up to approximately 3 years]
  • Clearance (CL) [Срок оценки: Up to approximately 3 years]
  • Terminal elimination rate constant (λz) [Срок оценки: Up to approximately 3 years]
Вторичные конечные точки (4)
  • Objective response rate (ORR), based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [Срок оценки: Up to approximately 3 years]
  • Duration of objective response (DOR), based on RECIST v1.1 [Срок оценки: Up to approximately 3 years]
  • Progression-free survival (PFS), based on RECIST v1.1 [Срок оценки: Up to approximately 3 years]
  • Overall survival (OS) [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

  • Aged 18 years or older
  • Have a confirmed diagnosis of ovarian cancer, including high-grade serous, high-grade endometrioid, low-grade serous, or clear cell ovarian cancer, or carcinosarcoma of the ovary. Patients with mucinous carcinoma are not eligible.
  • Have relapsed or refractory ovarian cancer and have already received standard treatments known to provide benefit; participants are eligible if they have platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer (with clearly documented ineligibility for further platinum chemotherapy).
  • Are able to understand the study requirements and are willing to provide written informed consent
  • Are willing to use effective birth control during the study and for a period after the last dose of study treatment, if of childbearing potential

Критерии исключения

  • Have another active cancer that could interfere with assessment of this study treatment
  • Have received another investigational drug or certain cancer treatments within a recent period before starting this study
  • Are pregnant or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • START Northwell, LLC — Lake Success
  • Start Ccbd, Llc — Fort Worth

Идентификаторы

NCT: NCT07690189 · NTB928.01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗