A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced 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: PRJ1-3024.
- Кому может быть актуально
- Состояния в реестре: Advanced Solid Tumor, Advanced Solid Malignancies. 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
- Китай
- 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, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
Обзор
This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.
Подробное описание
Using dose escalation, the study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.
Participants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors.
This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension study.
Вмешательства
- Препарат PRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day.
Первичные конечные точки
- Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period [Срок оценки: Day 1 to Day 21]
Вторичные конечные точки (6)
- Incidence of adverse events (AEs) [Срок оценки: 24 months]
- Pharmacokinetic parameter# Accumulation ratio [Срок оценки: 24 months]
- Objective response rate (ORR) [Срок оценки: 24 months]
- Duration of response (DOR) [Срок оценки: 24 months]
- Pharmacokinetic parameter#AUC0-last# [Срок оценки: 24 months]
- Pharmacokinetic parameter#Maximum observed concentration (Cmax) [Срок оценки: 24 months]
Критерии участия
\- Key Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.
- Male or non-pregnant, non-lactating female subjects age ≥18 years.
- ECOG Performance Status 0\~1.
- Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .
- Life expectancy of >3 months, in the opinion of the Investigator.
- Able to take oral medications and willing to record daily adherence to investigational product.
- Adequate hematologic parameters unless clearly due to the disease under study.
- Adequate renal and hepatic function
- Able to understand and willing to sign a written informed consent form.
Критерии исключения
- History of another malignancy
- Known symptomatic brain metastases requiring >10 mg/day of prednisolone.
- Significant cardiovascular disease.
- Known active HBV, HCV, AIDS-related illness.
- Has received a live vaccine within 30 days.
- History of active autoimmune disorders, or ongoing immunosuppressive therapy or ongoing .
- Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to < Grade 2.
- Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .
- Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.
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
Китай · 5 центров
- The first affiliated hospital of Zhengzhou University — Чжэнчжоу
- West China Hospital of Sichuan University — Чэнду
- Cancer hospital of the University of Chinese Academy of Sciences — Ханчжоу
- Beijing Cancer Hospital — Пекин
- The Fifth Medical Center of PLA General Hospital — Пекин
Идентификаторы
NCT: NCT05315167 · PRJ1-3024-001 · CXHL2101725