CT-95 in Advanced Cancers Associated With Mesothelin Expression
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: CT-95.
- Кому может быть актуально
- Состояния в реестре: Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer, Malignant Pleural Mesothelioma, Advanced, Malignant Peritoneal Mesothelioma, Advanced. 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
- 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
Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
Обзор
This is a Phase 1a/1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with advanced (recurrent, unresectable, or metastatic) cancers associated with MSLN expression.
Подробное описание
Phase 1a Dose Escalation: Participants with ovarian epithelial tumors, primary peritoneal or fallopian tube cancer (PROC), epithelioid mesothelioma, lung adenocarcinoma, pancreatic adenocarcinoma, colorectal cancer, cholangiocarcinoma, and gastric/GEJ adenocarcinomas will be enrolled in one of approximately 9 dose escalation cohorts to assess the safety and tolerability of CT-95, as well as determine the maximum tolerated dose (MTD) or other recommended dose(s) for expansion (RDE\[s\]) for further dose expansion cohorts.
Participants will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle.
Phase 1b Dose Expansion: The RDE(s) of CT-95 determined in Phase 1a will be evaluated in 2-4 indication-specific expansion cohorts of up to 20 subjects each (i.e. up to 80 participants total). Different indications, dose levels, and/or schedules may be explored. The expansion doses and/or dosing schedules for Phase 1b will be determined by Sponsor in conjunction with SRC based upon all available safety, PK, PD, biomarker, and preliminary efficacy data from Phase 1a.
Вмешательства
- Препарат CT-95
MSLN bispecific antibody to be administered according to the dose and schedule of the assigned cohort until documentation of disease progression (or confirmed disease progression), unacceptable toxicity, or participant/physician decision.
Первичные конечные точки
- Determine the MTD or RD of CT-95 [Safety and Tolerability] [Срок оценки: From date of first dose of CT-95 until 28 days following the first dose.]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.]
Вторичные конечные точки (6)
- Evaluate Response Rates [Anti-tumor Activity] [Срок оценки: At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first]
- Evaluate Progression-free Survival [Anti-tumor Activity] [Срок оценки: At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.]
- Evaluate Overall Survival [Survival] [Срок оценки: From the time of the first dose of CT-95 until approximately two years post-first dose.]
- Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics] [Срок оценки: From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.]
- Evaluate the Area Under the Curve (AUC) [Pharmacokinetics] [Срок оценки: From date of first dose of CT-95 for 5 months or treatment discontinuation, whichever comes first.]
- Evaluate Anti-Drug Antibodies [Immunogenicity] [Срок оценки: From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.]
Критерии участия
Критерии включения
- ECOG 0 or 1
- Subjects with evaluable disease per RECIST 1.1 or mRECIST
- Subjects with adequate organ function.
- Subjects with advanced cancers associated with mesothelin expression
Критерии исключения
- Uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study.
- Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy
- Concurrent participation in another investigational clinical trial.
- Evidence of leptomeningeal disease
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 · 9 центров
- Context Investigational Site — Denver
- Context Investigational Site — Chicago
- Context Investigational Site — Grand Rapids
- Context Investigational Site — Hackensack
- University of Pennsylvania — Philadelphia
- Context Investigational Site — Philadelphia
- Context Investigational Site — Nashville
- Context Investigational Site — San Antonio
- … и ещё 1 центр
Идентификаторы
NCT: NCT06756035 · CNTX-CT95-101