A Phase I Study to Assess the Safety, Tolerability, Radiation Dosimetry and Efficacy of [177Lu] Lu-PSMA-XT in Patients With Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- 1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
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 .
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
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
[177Lu]Lu-PSMA-XT
[177Lu]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells
干预措施: [177Lu]Lu-PSMA-XT (Drug)
结局指标
主要结局
1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Through study completion, assessed up to 2 years
To evaluate the safety and tolerability of \[177Lu\]Lu-PSMA-XT Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc.
Dose-limiting toxicity（DLT）
时间窗: Through study completion, assessed up to 2 years
Incidence and severity of dose-limiting toxicities.
Whole body and organ uptake of [177Lu]Lu-PSMA-XT Injection
时间窗: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
Quantitate the absorbed radiation doses (expressed as Gy/MBq) of administered \[177Lu\]Lu-PSMA-XT to kidneys, liver, lungs, spleen, bone/red marrow and salivary glands.
次要结局
- Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level(PCWG3)(Through study completion, assessed up to 2 years.)
- Prostate-specific Antigen 50 (PSA50) Response(Through study completion, assessed up to 2 years.)
- Time to PSA progression(Through study completion, assessed up to 2 years.)
- Radiographic Progression-free Survival (rPFS)(Through study completion, assessed up to 2 years.)
- Overall Response Rate (ORR)(Through study completion, assessed up to 2 years.)
- Duration of Response (DOR)(Through study completion, assessed up to 2 years.)
- Disease Control Rate (DCR)(Through study completion, assessed up to 2 years.)
- Time to First Symptomatic Skeletal Event (SSE)(Through study completion, assessed up to 2 years.)
研究者
Jinming Zhang
PI
Chinese PLA General Hospital