Идёт набор NCT06139575
Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate 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: Lutetium Lu 177 JH020002 Injection.
- Кому может быть актуально
- Состояния в реестре: Prostate Cancer. Базовые параметры: от 18 лет · Мужчины.
- 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
Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Preliminary Efficacy of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer
Обзор
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of Lutetium Lu 177 JH020002 Injection in adult patients with advanced prostate cancer.
Вмешательства
- Препарат Lutetium Lu 177 JH020002 Injection
Patients will receive Lutetium Lu 177 JH020002 Injection every 6 weeks for a maximum of 6 doses. Doses range between 1.85 and 8.88 GBq (50-240 mCi)
Первичные конечные точки
- Dose Limiting Toxicity (DLT) (Phase 1) [Срок оценки: Up to 2 years follow up]
- Maximum Tolerated Dose (MTD) (Phase 1) [Срок оценки: Up to 2 years follow up]
- Recommended Phase 2 Dose (RP2D) (Phase 1) [Срок оценки: Up to 2 years follow up]
- PSA response rate [Срок оценки: Up to 3 years follow up]
Вторичные конечные точки (12)
- Radiation Dosimetry [Срок оценки: Up to 2 years follow up]
- Maximum plasma concentration (Cmax) [Срок оценки: Up to 2 years follow up]
- Time to maximum plasma concentration (Tmax) [Срок оценки: Up to 2 years follow up]
- Terminal elimination half-life (t1/2) [Срок оценки: Up to 2 years follow up]
- Total systemic clearance (CL) [Срок оценки: Up to 2 years follow up]
- Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) [Срок оценки: Up to 2 years follow up]
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-inf) [Срок оценки: Up to 2 years follow up]
- Volume of distribution (Vz) during the terminal phase following intravenous elimination [Срок оценки: Up to 2 years follow up]
- Radiographic Progression-free Survival (rPFS) [Срок оценки: Up to 3 years follow up]
- Disease control Rate (DCR) [Срок оценки: Up to 3 years follow up]
- Duration of Response (DoR) [Срок оценки: Up to 3 years follow up]
- Time to First Subsequent Therapy (TFST) [Срок оценки: Up to 3 years follow up]
Критерии участия
Критерии включения
- Subjects are required to get informed consent prior to the trial and sign a written informed consent form voluntarily.
- Male, age ≥18 years.
- ECOG score 0 - 2.
- Must have a life expectancy >6 months.
- Histologically and/or cytologically confirmed adenocarcinoma of the prostate (except for those with neuroendocrine or small cell prostate cancer clinical features).
- Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dl, or < 1.7nmol/L).
Критерии исключения
- Diagnosed with other malignancies, apart from: adequately treated skin basal cell carcinoma or superficial bladder cancers from which the patient has been disease-free for more than 3 years as confirmed by a physician.
- Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
- Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation <6 months prior to date of first administration of investigational drug.
- Previous PSMA-targeted radioligand therapy.
- Previous radiotherapy for prostate cancer within 4 weeks prior to date of first administration of investigational drug.
- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy, poly adenosine diphosphate-ribosyl polymerase inhibitors (PARPi) or biological therapy within 4 weeks prior to date of first administration of investigational drug.
- Must not take part in other investigational therapies within 4 weeks prior to date of first administration of investigational drug.
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 13 центров
- Anhui Provincial Hospital — Хэфэй
- Peking University First Hospital — Пекин
- The First Affiliated Hospital of Fujian Medical University — Фучжоу
- Sun Yat-Sen University Cancer Center — Гуанчжоу
- Henan Cancer Hospital — Чжэнчжоу
- Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hosp — Ухань
- The First Affiliated Hospital of Soochow University — Сучжоу
- Affiliated Hospital of Jiangsu University — Wuxi
- … и ещё 5 центров
Идентификаторы
NCT: NCT06139575 · JH020002-01C