NCT04634344终止1 期
A Phase I, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD2269 in Patients With Metastatic Castration Resistant Prostate Cancer
Dizal Pharmaceuticals6 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2021年4月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Incidence of AEs and SAEs
研究概览
简要总结
This study will treat patients with Metastatic Castration Resistant Prostate Cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
详细描述
A first-time-in-human, Phase I, open-label, multicenter study to determine safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of DZD2269 in patients with mCRPC.
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
- •Informed consent form, taken prior to any study specific procedures, sampling and/or analyses.
- •Male patients age ≥ 18 years (≥ 19 in S. Korea), ECOG status 0-1, Predicted life expectancy ≥ 12 weeks,
- •All patients enrolled must have histologically confirmed diagnosis of adenocarcinoma of the prostate, with metastatic disease, and must also previously progressed on standard-of-care (SoC) therapy (i.e., abiraterone or enzalutamide, taxanes such as docetaxel or cabazitaxel) despite castrate levels of testosterone.
- •Be willing to provide blood samples and paired tumor tissue (if accessible) for the exploratory biomarker research
- •Total testosterone < 50 ng/dL at screening (except for subjects with prior orchiectomy, where testosterone does not need to be measured).
- •Adequate bone marrow reserve and organ system functions
- •LVEF ≥ 55% assessed by ECHO or MUGA
排除标准
- •Cytotoxic chemotherapy from a previous treatment regimen within 21 days of the first dose of study treatment.
- •Major surgery procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.
- •Prior exposure to therapeutic anticancer vaccines
- •Prior immune-mediated therapy including, but not be limited to, anti-CTLA-4, anti-PD1, anti-PDL1 and anti-PDL2 must have a wash-out period of ≥ 30 days before dosing
- •Prior/concomitant therapy with any other A2aR antagonist.
- •Live vaccines within 28 days prior to first dose.
- •Radiotherapy with a limited field for palliation within 1 week of the first dose of study treatment.
- •Patients currently receiving (or unable to stop using) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A4, sensitive CYP3A4 substrates with narrow therapeutic index, and sensitive MATE1 and MATE2-K substrates with narrow therapeutic range
- •Any unresolved toxicities > Grade 1 (except alopecia).
- •Bone pain due to metastatic bone disease that cannot be managed with a routine, stable dose of a narcotic analgesic
- •Active infections as outlined in protocol
- •Spinal cord compression.
- •Patients who require systemic use of corticosteroids (at any dose)
- •Refractory nausea and vomiting if not controlled by supportive therapy
- •Cardiac criteria as outlined in protocol
- •Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer or other cancer from which the patient has been disease free for ≥ 2 years or which will not limit survival to < 2 years
研究组 & 干预措施
DZD2269 as monotherapy
Experimental
干预措施: DZD2269 (Drug)
结局指标
主要结局
Incidence of AEs and SAEs
时间窗: From screening to 28 days after the last dose
To investigate the safety and tolerability of DZD2269 as monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC)
Incidence of DLTs
时间窗: From the first dose of study treatment up to the last day of Cycle 1 (28 days after start of multiple dosing)
To establish Maximum Tolerated Dose (MTD) (if possible) in patients with mCRPC
次要结局
- Drug concentrations of DZD2269 in plasma and urine(to approximately 6 months)
- Maximum plasma concentration (Cmax) of DZD2269(up to approximately 6 months)
- Area under the plasma concentration-time curve (AUC) of DZD2269(up to approximately 6 months)
- Duration of Response (DoR)(Through the study completion, an average of around 1 year)
- Objective Response Rate (ORR)(Through the study completion, an average of around 1 year)
- Disease Control Rate (DCR);(Through the study completion, an average of around 1 year)
研究者
研究点 (6)
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