NCT02991911已完成1 期
A Phase 1/1b Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI3726 in Subjects With Metastatic Castration Resistant Prostate Cancer Who Have Received Prior Treatment With Abiraterone or Enzalutamide.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Number of patients with changes in vital signs from baseline
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI3726 in subjects with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of screening.
- •Histologically confirmed diagnosis of metastatic castration-resistant prostate adenocarcinoma (mCRPC).
- •Documented PD in subjects with mCRPC as assessed by the Investigator and defined by at least one of the following according to the PCWG3 criteria:
- •Radiographic progression.
- •PSA progression.
- •Prior exposure to abiraterone or enzalutamide of at least 12 weeks in the mCRPC setting.
- •NOTE: Subjects who have received both abiraterone and enzalutamide in the mCRPC setting are eligible.
- •In dose escalation: Prior taxane-based chemotherapy in the mCRPC setting is:
- •Required for Arm A.
- •Excluded for Arm B.
- •Optional for Arm C.
排除标准
- •Subjects with neuroendocrine, neuroendocrine differentiation and/or small cell prostate cancer.
- •The subject has received any conventional or investigational anti-cancer treatment within 21 days before the first dose of investigational product, with the following modifications:
- •At least 14 days before the first dose of investigational product since completion of treatment with abiraterone or enzalutamide
- •At least 14 days before the first dose of investigational product since completion of prior taxane-based chemotherapy
- •At least 28 days before the first dose of investigational product since completion of treatment with Radium-
- •At least 42 days before the first dose of investigational product since completion of prior bicalutamide and nilutamide treatment.
- •NOTE: An LHRH agonist or antagonist required for ongoing testosterone suppression will be permitted if Inclusion Criterion is satisfied.
- •Prior exposure to PSMA-directed therapies.
- •Subjects with previous radiotherapy for the treatment of unresectable, locally advanced or metastatic prostate cancer are excluded if:
- •More than 25% of marrow-bearing bone has been irradiated.
- •The last fraction of radiotherapy has been administered within approximately 2 weeks prior to the first dose of investigational product.
- •Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to the first dose of investigational product.
- •Subjects with known history of peripheral vasculopathies including, but not limited to, macro and microangiopathies secondary to diabetes, peripheral arteriopathy of any cause, intermittent claudication, repeated and/or non-healing ulcers of any cause.
结局指标
主要结局
Number of patients with changes in vital signs from baseline
时间窗: From time of informed consent through 21 days after last dose of MEDI3726
Safety Endpoint
Number of patients with changes in laboratory parameters from baseline
时间窗: From time of informed consent through 90 days after last dose of MEDI3726
Safety Endpoint
Occurrence of adverse events (AEs)
时间窗: From time of informed consent through 90 days after last dose of MEDI3726
Safety Endpoint
Occurrence of serious adverse events (SAEs)
时间窗: From time of informed consent through 90 days after last dose of MEDI3726
Safety Endpoint
Occurrence of dose-limiting toxicities (DLTs)
时间窗: From time of first dose through 21 days after first dose of MEDI3726
Safety Endpoint
Number of patients with changes in electrocardiogram (ECG) results from baseline
时间窗: From time of informed consent through 21 days after last dose of MEDI3726
Safety Endpoint
次要结局
- PSA50 response(From time of fist dose through at least 12 weeks after first dose of MEDI3726)
- MEDI3726 plasma concentrations for pharmacokinetics (PK)(From time of informed consent through 90 days after last dose of MEDI3726)
- MEDI3726 terminal half-life for PK(From time of informed consent through 90 days after last dose of MEDI3726)
- Response Evaluation Criteria in Solid Tumors (RECIST) response(From time of informed consent through 90 days after last dose of MEDI3726)
- Circulating Tumor Cell (CTC) response(From time of informed consent through 90 days after last dose of MEDI3726)
- Number and percentage of subjects who develop anti-drug antibodies (ADAs)(From time of informed consent through 90 days after last dose of MEDI3726)
- MEDI3726 area under the concentration-time curve for PK(From time of informed consent through 90 days after last dose of MEDI3726)
- MEDI3726 maximum observed concentration for PK(From time of informed consent through 90 days after last dose of MEDI3726)
- Safety and tolerability of MEDI3726 in combination with Enzalutamide(From time of informed consent through 90 days after last dose of MEDI3726 with enzalutamide)
- MEDI3726 clearance for PK(From time of informed consent through 90 days after last dose of MEDI3726)
研究者
研究点 (6)
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