Safety, Dosimetry, and Preliminary Efficacy of 3D1015 Injection in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): An Open-Label Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •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).
排除标准
- •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.
研究组 & 干预措施
Lu 177-PSMA-3D1015
干预措施: Lu 177-PSMA-3D1015 Injection (Drug)
结局指标
主要结局
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
时间窗: From first dose of study drug through end of treatment (~36-48 weeks)
Safety and tolerability will be evaluated by monitoring the incidence and severity of TEAEs.
Occurrence of Dose-Limiting Toxicities (DLTs)
时间窗: From first dose of study drug through end of treatment (~36-48 weeks)
Number of participants experiencing dose-limiting toxicities (DLTs) .
Absorbed Dose
时间窗: From first dose of study drug through end of treatment (~36-48 weeks)
Absorbed dose to the whole body, critical organs (e.g., kidneys, salivary glands), and tumor lesions assessed via serial imaging data.
Effective Half-Life
时间窗: From first dose of study drug through end of treatment (~36-48 weeks)
Effective half-life of the study drug in the whole body, major organs, and tumor lesions determined by serial imaging.
次要结局
- The proportion of patients with a PSA change from baseline(From first dose of study drug through end of treatment (~36-48 weeks))
- Objective Response Rate (ORR)(From first dose of study drug through efficacy follow-up period (Up to approximately 5 years))
- Radiographic progression-free survival (rPFS)(From first dose of study drug through efficacy follow-up period (Up to approximately 5 years))
研究者
Chunjing Yu
Attending Physician
Affiliated Hospital of Jiangnan University