CR-001 in Adult Participants With Locally Advanced or Metastatic 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: CR-001.
- Кому может быть актуально
- Состояния в реестре: Locally Advanced / Metastatic Solid Tumors. 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, Австралия, Ирландия, Италия, 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, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Обзор
The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), and/or optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.
Подробное описание
The study will initially comprise 3 parts: dose escalation, backfill, and dose optimization cohorts. The study will follow a stepwise approach, beginning with a typical dose escalation in participants with selected indications of advanced solid tumors. Additional participants will enroll in the backfill part at select dose levels that have been previously cleared for safety by the safety review committee. In dose optimization, participants will be randomized to one of two CR-001 dose levels.
All participants will undergo a screening period, a treatment period of up to 2 years, a safety follow-up period, and long-term efficacy and survival follow-up. During the treatment period, participants will undergo clinical and safety assessments including disease assessment scans and blood laboratory safety, pharmacokinetic, and pharmacodynamic assessments. After treatment ends, disease scans will continue until disease progression, and long-term follow-up visits will be conducted by telephone every 3 months.
Вмешательства
- Препарат CR-001
Intravenous Infusion
Первичные конечные точки
- Dose Escalation - Incidence and nature of dose-limiting toxicities [Срок оценки: From the first dose of study drug up until approximately 1 month]
- Dose Escalation - Characterization of the maximum tolerated dose, if applicable [Срок оценки: From the first dose of study drug up until approximately 1 month]
- All parts - Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment - emergent serious adverse events [Срок оценки: From the first dose of study drug until 90 days after the last dose of study drug]
- All parts - Incidence and severity of TEAEs leading to dose modifications [Срок оценки: From the first dose of study drug until 90 days after the last dose of study drug]
- All parts - Incidence and severity of TEAEs leading to treatment discontinuation [Срок оценки: From the first dose of study drug until 90 days after the last dose of study drug]
Вторичные конечные точки (12)
- All parts - Determination of recommended Phase 2 dose(s) [Срок оценки: From the first dose of study drug until 90 days after the last dose of study drug]
- All parts - Serum CR-001 pharmacokinetic parameters [Срок оценки: Predose until up to approximately 36 months]
- All parts - Serum CR-001 pharmacokinetic parameters [Срок оценки: Predose until up to approximately 36 months]
- All parts - Serum CR-001 pharmacokinetic parameters [Срок оценки: Predose until up to approximately 36 months]
- All parts - Serum CR-001 pharmacokinetic parameters [Срок оценки: Predose until up to approximately 36 months]
- All parts - Serum CR-001 pharmacokinetic parameters [Срок оценки: Predose until up to approximately 36 months]
- All parts - Serum CR-001 pharmacokinetic parameters [Срок оценки: Predose until up to approximately 36 months]
- All parts - Serum CR-001 pharmacokinetic parameters [Срок оценки: Predose until up to approximately 36 months]
- All parts - Incidence of participants with detectable antidrug antibodies [Срок оценки: Predose until up to approximately 36 months]
- All parts - Overall response rate [Срок оценки: From the first dose of study drug until up to approximately 36 months]
- All parts - Duration of response [Срок оценки: From the first dose of study drug until up to approximately 36 months]
- All parts - Time to response [Срок оценки: From the first dose of study drug until up to approximately 36 months]
Критерии участия
Критерии включения
- Life expectancy ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
- Adequate organ function and hematologic reserve based on laboratory parameters
- Have measurable disease defined by RECIST v1.1
- For Backfill and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy
- Tumor Indication specific inclusion criteria:
- For dose escalation or backfill: progressing from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types:
- Hepatocellular carcinoma
- Biliary tract cancer
- Endometrial carcinoma
- Cervical cancer
- Ovarian cancer
- Gastric or gastroesophageal cancer
- Colorectal cancer
- Non-small cell lung cancer
Критерии исключения
- Has malignancies other than disease under study within the past 3 years
- Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy
- Has not adequately recovered from recent major surgery
- Has ongoing clinically significant toxicity related to prior therapy
- Has active central nervous system (CNS) metastases
- Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted)
- Has a history of serious Grade ≥ 3 immune-related adverse event (irAE)
- Has a history of noninfectious pneumonitis/interstitial lung disease
- Has an active severe infection
- Has received a live or attenuated vaccine within 30 days of the first dose
- Has undergone prior allogeneic stem cell or solid organ transplantation
- Has protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleeding
- Has clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
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 · 14 центров
- Clinical Study Site — Birmingham
- Clinical Study Site — Los Angeles
- Clinical Study Site — Denver
- Clinical Study Site — Orlando
- Clinical Study Site — Sarasota
- Clinical Study Site — Detroit
- Clinical Study Site — Grand Rapids
- Clinical Study Site — New York
- … и ещё 6 центров
South Korea · 4 центра
- Clinical Study Site — Seoul
- Clinical Study Site — Seoul
- Clinical Study Site — Seoul
- Clinical Study Site — Seongnam-si
Испания · 3 центра
- Clinical Study Site — Barcelona
- Clinical Study Site — Logroño
- Clinical Study Site — Madrid
Румыния · 2 центра
- Clinical Study Site — Cluj-Napoca
- Clinical Study Site — Bucharest
Австралия · 1 центр
- Clinical Study Site — South Brisbane
Ирландия · 1 центр
- Clinical Study Site — Dublin
Италия · 1 центр
- Clinical Study Site — Milan
Идентификаторы
NCT: NCT07335497 · CR-001-101 · 2025-523590-42-00