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Идёт набор NCT07096128

A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer

Фаза I С лечением mCRPC

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: [177Lu]Lu-PSMA-XT.
Кому может быть актуально
Состояния в реестре: mCRPC. 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
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Официальное название

A Phase I Study to Assess the Safety, Tolerability, Radiation Dosimetry and Efficacy of [177Lu] Lu-PSMA-XT in Patients With Metastatic Prostate Cancer

Обзор

This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of \[177Lu\] Lu-PSMA-XT injection in patients with metastatic prostate cancer .

Вмешательства

  • Препарат [177Lu]Lu-PSMA-XT
    \[177Lu\]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells.

Первичные конечные точки

  • 1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: Through study completion, assessed up to 2 years]
  • Dose-limiting toxicity（DLT） [Срок оценки: Through study completion, assessed up to 2 years]
  • Whole body and organ uptake of [177Lu]Lu-PSMA-XT Injection [Срок оценки: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months]
Вторичные конечные точки (8)
  • Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level(PCWG3) [Срок оценки: Through study completion, assessed up to 2 years.]
  • Prostate-specific Antigen 50 (PSA50) Response [Срок оценки: Through study completion, assessed up to 2 years.]
  • Time to PSA progression [Срок оценки: Through study completion, assessed up to 2 years.]
  • Radiographic Progression-free Survival (rPFS) [Срок оценки: Through study completion, assessed up to 2 years.]
  • Overall Response Rate (ORR) [Срок оценки: Through study completion, assessed up to 2 years.]
  • Duration of Response (DOR) [Срок оценки: Through study completion, assessed up to 2 years.]
  • Disease Control Rate (DCR) [Срок оценки: Through study completion, assessed up to 2 years.]
  • Time to First Symptomatic Skeletal Event (SSE) [Срок оценки: Through study completion, assessed up to 2 years.]

Критерии участия

Критерии включения

  • Patients must have the ability to understand and sign an approved informed consent form (ICF).
  • Patients must be >= 18 and <＝80 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must have a life expectancy >6 months.
  • Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
  • Patients must be PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
  • Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
  • Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone)； patients must have been previously treated undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.
  • Patients must have progressive mCRPC.
  • Patients must have adequate organ function。
  • Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.

Критерии исключения

  • Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
  • Known other malignancies.
  • Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
  • Known hypersensitivity to the components of the study therapy or its analogs.
  • A superscan as seen in the baseline bone scan.
  • Patients with a history of Central Nervous System (CNS) metastases.
  • Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 3 центра
  • Beijing Cancer Hospital — Пекин
  • Mianyang Central Hospital — Пекин
  • The First Medical Center, Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT07096128 · IIT-XTR021-1-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗