A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer

Обзор

The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC

Вмешательства

• Препарат 225Ac-PSMA-XT
  Patients will receive 225Ac-PSMA-XT administration at an interval of 6 weeks between each dose.

Первичные конечные точки

• Treatment emergent adverse events [Срок оценки: Through study completion, assessed up to 2 years]
• Dose-limiting toxicity（DLT） [Срок оценки: Through study completion, assessed up to 2 years]

Вторичные конечные точки (5)

• Prostate-specific Antigen 50 (PSA50) Response [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.]

Критерии участия

Критерии включения

• have the ability to understand and sign an approved informed consent form (ICF).
• >= 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• have a life expectancy >6 months.
• have histological, pathological, and/or cytological confirmation of prostate cancer.
• PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive
• have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
• 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.
• progressive mCRPC.
• 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

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hospital of Shandong First Medical University — Цзинань

Идентификаторы

NCT: NCT07135102 · SDZLEC2024-365-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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