A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
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: STRO-004, Pembrolizumab.
- Кому может быть актуально
- Состояния в реестре: Head and Neck Squamous Cell Carcinoma HNSCC, Non-Small Cell Lung Cancer NSCLC, Esophageal Cancer, Gastric 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 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent Metastatic Solid Tumors
Обзор
This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts: * Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF). * Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity. * Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.
Вмешательства
- Препарат STRO-004
IV Infusion - Препарат Pembrolizumab
IV Infusion
Первичные конечные точки
- Part 1A: Number of participants with Dose-limiting Toxicities (DLTs) [Срок оценки: Up to Day 21]
- Part 1A, 1B: Percentage of participants with Treatment-Emergent Adverse Events (TEAEs), with severity determined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale [Срок оценки: Up to 12 Months]
- Part 1A, 1B, 1C: Percentage of participants with clinical laboratory abnormalities, with severity determined according to the CTCAE v5.0 grading scale [Срок оценки: Up to 12 months]
- Part 1B: Objective Response Rate (ORR) [Срок оценки: Up to 12 months]
- Part 1B: Disease control rate (DCR) [Срок оценки: Up to 12 months]
- Part 1B: Duration of Response (DOR) [Срок оценки: Up to 12 months]
- Part 1B: Progression-Free Survival (PFS) [Срок оценки: Up to 12 months]
- Part 1B: 12-month survival rate [Срок оценки: 12 months]
- Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale [Срок оценки: Up to 12 months]
Вторичные конечные точки (7)
- Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints [Срок оценки: Up to 12 months]
- Part 1A, 1B, 1C: Immunogenicity [Срок оценки: Up to 12 months]
- Part 1A: Objective Response Rate (ORR) [Срок оценки: Best response of CR or PR per RECIST V1.1]
- Part 1A, 1C: Disease Control Rate (DCR) [Срок оценки: Up to 12 months]
- Part 1A, 1C: Duration of Response (DOR) [Срок оценки: Up to 12 months]
- Part 1A,1C: Progression-Free Survival (PFS) [Срок оценки: Up to 12 months]
- Part 1A,1C: 12-month survival rate [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal/Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies
- Availability of tumor tissue
- Measurable disease per RECIST 1.1
- Adequate organ function
- Participants receiving anticoagulants must be on a stable dose
Критерии исключения
- Eye disorders
- Untreated brain metastases
- Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
- Previous solid organ or bone marrow transplantation
- Concurrent participation in another therapeutic treatment trial
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
США · 9 центров
- UC San Diego Moores Cancer Center — San Diego
- SCRI Denver — Denver
- Georgetown University Medical Center — Washington D.C.
- SCRI FCS Sarasota — Sarasota
- Mass General Cancer Center — Boston
- Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai — New York
- NEXT Austin — Austin
- NEXT San Antonio — San Antonio
- … и ещё 1 центр
Идентификаторы
NCT: NCT07227168 · STRO-004-ST1