3D1015 Injection for Patients With mCRPC

Официальное название

Safety, Dosimetry, and Preliminary Efficacy of 3D1015 Injection in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): An Open-Label Clinical Study

Обзор

This open-label clinical study investigates 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Participants will receive intravenous infusions of 3D1015, with treatment regimens dynamically individualized to optimize patient safety and outcomes. The primary objectives are to assess the safety, tolerability, and dosimetry of the injection. Secondary objectives include evaluating preliminary anti-tumor efficacy and exploring the optimal dosing regimen.

Вмешательства

• Препарат Lu 177-PSMA-3D1015 Injection
  3D1015 is administered intravenously at an individualized dose.

Первичные конечные точки

• Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: From first dose of study drug through end of treatment (~36-48 weeks)]
• Occurrence of Dose-Limiting Toxicities (DLTs) [Срок оценки: From first dose of study drug through end of treatment (~36-48 weeks)]
• Absorbed Dose [Срок оценки: From first dose of study drug through end of treatment (~36-48 weeks)]
• Effective Half-Life [Срок оценки: From first dose of study drug through end of treatment (~36-48 weeks)]

Вторичные конечные точки (3)

• The proportion of patients with a PSA change from baseline [Срок оценки: From first dose of study drug through end of treatment (~36-48 weeks)]
• Objective Response Rate (ORR) [Срок оценки: From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)]
• Radiographic progression-free survival (rPFS) [Срок оценки: From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)]

Критерии участия

Критерии включения

• Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits.
• Male, aged 18 years or older.
• Histologically or cytologically confirmed prostate adenocarcinoma.
• Castrate levels of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
• Must be 68Ga-PSMA PET/CT scan positive.
• ECOG performance status of 0 to 2.
• Confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) that is refractory to or has progressed following prior treatments.
• Presence of at least one metastatic lesion at baseline.
• Adequate Organ Function.
• Resolution of all prior treatment-related toxicities to Grade ≤ 2 (excluding alopecia).

Критерии исключения

• Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.
• Life expectancy of < 6 months, as assessed by the investigator.
• A superscan as seen in the baseline bone scan.
• Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments.
• Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds.
• Any medical, psychiatric, or logistical condition that, per investigator judgment, would preclude protocol compliance or compromise patient safety.

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 · 1 центр

• Jiangnan University Affiliated Hospital — Wuxi

Идентификаторы

NCT: NCT07537010 · 3D1015-CN-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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