A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
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: CRB-701, Anti-PD-1.
- Кому может быть актуально
- Состояния в реестре: Solid Tumor, Adult. 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, Франция, Италия, Moldova, Румыния +2
- 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 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors
Обзор
The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4. The main questions it aims to answer are: What is the the safe and effective dose of CRB-701? What cancers can be treated effectively with CRB-701? Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701. They will have blood tests, CT or MRI Scans, and other assessments to measure whether CRB-701 has an effect on tumors.
Подробное описание
This is a three-part open-label, Phase 1/2 clinical trial designed to evaluate the safety, PK, and efficacy of CRB-701 in participants with advanced solid tumors expressing nectin-4.
Part A will include solid tumor types known to express nectin-4. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design to determine the Maximum Tolerated Dose (MTD) of CRB-701. Four (4) dose groups are pre-determined. Dose escalation/de-escalation decisions are made based on the occurrence of DLT.
Part B will evaluate two dose levels of CRB-701 alone and in combination with anti-PD-1 by using a time-to-event Bayesian optimal Phase 2 study design to optimize the dose of CRB-701 in one or more separate cohorts of participants with nectin-4-positive tumors.
During Part C, the recommended dose level of CRB-701 for further exploration defined in Part B will explore CRB-701 alone or combined with anti-PD-1 in up to seven separate cohorts of participants with advanced tumors known to express Nectin-4.
Вмешательства
- Препарат CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC) - Препарат Anti-PD-1
checkpoint inhibitor
Первичные конечные точки
- Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701 [Срок оценки: 21 days]
- Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR) [Срок оценки: Up to 6 months]
Вторичные конечные точки (12)
- Parts A, B, & C: To characterize the safety profile of CRB-701 [Срок оценки: Up to 6 months]
- Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax) [Срок оценки: Approximately 9 weeks]
- Maximum observed plasma concentration of free MMAE (Cmax) [Срок оценки: Approximately 9 weeks]
- Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR) [Срок оценки: Up to 6 months]
- Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax) [Срок оценки: Approximately 9 weeks]
- Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax) [Срок оценки: Approximately 9 weeks]
- Time to reach Cmax of free MMAE (Tmax) [Срок оценки: Approximately 9 weeks]
- Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax) [Срок оценки: Approximately 9 weeks]
- Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax) [Срок оценки: Approximately 9 weeks]
- Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC) [Срок оценки: Approximately 9 weeks]
- Total Area Under the plasma concentration-time curve of free MMAE (AUC) [Срок оценки: Approximately 9 weeks]
- Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC) [Срок оценки: Approximately 9 weeks]
Критерии участия
Критерии включения
- Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed having exhausted all appropriate lines of therapy or have no other standard therapy with proven clinical benefit. In Part C, HNSCC participants may enroll as first-line therapy.
Критерии исключения
- Active of uncontrolled CNS metastases
- History of solid tumors other than the diseases under study
- History of and/or current cardiovascular events or conditions in the previous 6 months
- Pre-existing >/= Grade 2 neuropathy
- Hemoglobin A1C (HbA1C) >/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy
- Active ocular disease at baseline
- Chronic severe liver disease or live cirrhosis
- Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study
- Other significant cormorbidities.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 15 центров
- O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham — Birmingham
- City of Hope Cancer Center — Duarte
- Moores Cancer Centre at UC San Diego Health — San Diego
- Helen Diller Family Comprehensive Cancer Center - UCSF — San Francisco
- Rocky Mountain Cancer Centres — Denver
- Yale Cancer Center — New Haven
- Florida Cancer Specialists — Orlando
- University of Chicago — Chicago
- … и ещё 7 центров
Великобритания · 9 центров
- University of Birmingham NHS Foundation Trust — Birmingham
- University of Cambridge NHS Foundation Trust — Cambridge
- Velindre Cancer Centre — Cardiff
- Leeds University Hospitals NHS Trust — Leeds
- Guy's and St Thomas' Clinical Research Facility — London
- Imperial Experimental Cancer Medicine Centre — London
- The Christie Hospital — Manchester
- University of Liverpool - Clatterbridge Medical Centre — Metropolitan Borough of Wirral
- … и ещё 1 центр
Франция · 4 центра
- ICM-Val d'Aurelle — Montpellier
- CHU de Poitiers — Poitiers
- Institut de Cancerologie de l'Ouest — Saint-Herblain
- Gustave Roussy — Villejuif
Италия · 4 центра
- Careggi University Hospital — Florence
- European Institute of Oncology IRCCS — Milan
- Fondazione Policlinico Gemelli, IRCCS — Rome
- Centro Richerche Cliniche di Verona — Verona
Румыния · 4 центра
- Aresnsia Research Clinic Bucharest — Bucharest
- Aresnsia Research Clinic Cluj-Napoca — Cluj-Napoca
- Centrul de Oncologie Sf. Nectarie — Iași
- Centrul de Oncologie Euroclinic — Iași
Испания · 4 центра
- Barcelona IOB Hospital Quironsalud (NEXT) — Barcelona
- Vall d-Hebron Institut d'Oncologia — Barcelona
- Fundacion Jimenez Diaz (START) — Madrid
- Hospital Clinico Universitario de Valencia — Valencia
Moldova · 1 центр
- Institute of Oncology/ARENSIA Exploratory Medicine — Chisinau
Идентификаторы
NCT: NCT06265727 · CRB-701-01