TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
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: TTX-080, TTX-080, pembrolizumab, cetuximab.
- Кому может быть актуально
- Состояния в реестре: Cancer. 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
A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant Malignancies
Обзор
TTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.
Подробное описание
TTX-080 is a fully human mAb designed to block the interaction of HLA-G with its known ligands, ILT2 and ILT4 molecules. The Phase 1a was an open label, multicenter, dose escalation clinical trial to determine the safety, tolerability, MTD or OBD, and the RP2D of TTX-080 when administered as a single agent. The Phase 1b is a dose expansion of TTX-080 monotherapy and in combination with either pembrolizumab or cetuximab in adult subjects with advanced refractory/resistant solid malignancies, including Head and Neck squamous cell carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Colorectal cancer (CRC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), and acral melanoma. Additionally, the Phase 1b includes randomized arms with TTX-080 in combination with FOLFIRI plus cetuximab compared to FOLFIRI plus cetuximab in metastatic Colorectal cancer. The study will seek to evaluate the pharmacokinetics and immunogenicity of TTX-080, and characterize the anti-tumor activity of TTX-080 as a monotherapy and in combination with pembrolizumab, cetuximab or FOLFIRI plus cetuximab. Only arm 9 and 10 are currently open to enrollment.
Вмешательства
- Препарат TTX-080
Variable dose (Q3W) - Препарат TTX-080
Specified dose (Q3W) - Препарат pembrolizumab
Specified dose (Q3W) - Препарат cetuximab
Specified dose on specified days - Препарат FOLFIRI
Specified dose (Q2W) - Препарат cetuximab
Specified dose (Q2W) - Препарат TTX-080
Specified dose (Q2W)
Первичные конечные точки
- 1. To determine the anti-tumor activity of TTX-080 by objective response rate [complete response + partial response) for each tumor arm per RECIST 1.1 [Срок оценки: Up to 48 months]
Вторичные конечные точки (9)
- Duration of Response, Progression Free Survival per RECIST 1.1 [Срок оценки: Up to 48 months]
- Overall Survival [Срок оценки: Up to 48 months]
- Adverse events (AEs) as characterized by the incidence, type, frequency, severity (graded according to NCI-CTCAE v5.0), timing, seriousness, and relationship to investigational product, and/or combination therapy, and/or individual approved therapies [Срок оценки: Up to 48 months]
- Tolerability: The number of cycles of TTX-080 received by patients before discontinuing due to unmanageable drug reactions [Срок оценки: Up to 48 months]
- Serum levels of Anti Drug Antibody against TTX-080 [Срок оценки: Up to 48 months]
- Cmax: Maximum Observed Plasma Concentration for TTX-080 [Срок оценки: Up to 48 months]
- Tmax: Time to Reach the Cmax for TTX-080 [Срок оценки: Up to 48 months]
- AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for TTX-080 [Срок оценки: Up to 48 months]
- AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for TTX-080 [Срок оценки: Up to 48 months]
Критерии участия
Abbreviated Inclusion Criteria:
- Subject with histological diagnosis of advanced/metastatic cancer \[currently enrolling in CRC only\]
- Age 18 years or older, is willing and able to provide informed consent
- Evidence of measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks
Abbreviated Exclusion Criteria:
- History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody
- Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study
- Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
- History of severe autoimmune disease
- Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 41 центр
- Arizona Oncology Associates — Tucson
- University of Southern California — Los Angeles
- Hoag Memorial Hospital — Newport Beach
- Rocky Mountain Cancer Centers — Denver
- Yale Cancer Center — New Haven
- Christiana Care Helen F. Graham Cancer Center — Newark
- John Hopkins Kimmer Cancer Center — Washington D.C.
- Florida Cancer Specialists — Daytona Beach
- … и ещё 33 центра
Идентификаторы
NCT: NCT04485013 · TTX-080-001