NCT04995042已完成1 期
An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse Events（AEs）
研究概览
简要总结
This is an open-label, multicenter, dose escalation and expansion Phase 1 study of SHR7280 in adult patients with hormone sensitive 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
- •Ability to understand and the willingness to sign a written informed consent document；
- •Age ≥18 years old;
- •Histologically or cytologically confirmed prostate adenocarcinoma;
- •Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer；
- •Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol；
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- •Adequate organ performance based on laboratory blood tests;
- •Agree to use adequate contraception prior to study entry and for the duration of study participation.
排除标准
- •Previously received gonadotropin-releasing hormone analogues (GnRH-a) for more than 12 months total duration (if GnRH-a was received for 12 months or less, then that GnRH-a must have been completed washout period prior to the first dose of study drug).
- •Patients who have received chemotherapy for prostate cancer;
- •History of surgical castration;
- •Received Abiraterone acetate with 3 months prior to the first dose of study drug;
- •Receieved molecular target therapy, immunotherapy, androgen receptor blockade, 5-alpha reductase inhibitors, estrogen, and other investigational compound with 4 weeks prior to the first dose of study drug;
- •Patients with known or suspected brain metastasis；
- •Diagnosis or treatment for another systemic malignancy within 5 years before study treatment initiation;
- •Patients with uncontrolled and clinically significant hypertension and diabetes;
- •Known hypersensitivity to SHR7280, SHR7280 excipients,；
- •History of immunodeficiency (including HIV infection) or organ transplantation;
- •Known active hepatitis B or C infection;
- •Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
研究组 & 干预措施
SHR7280 Does Escalation and Expansion
Experimental
干预措施: SHR7280 (Drug)
结局指标
主要结局
Adverse Events（AEs）
时间窗: 30 days after last dose
Dose Limited Toxicity (DLT)
时间窗: 28 Days (first cycle)
Maximum tolerable dose (MTD)
时间窗: 28 Days (first cycle）
Recommended dose for phase II (RP2D)
时间窗: Up to 12 months
次要结局
- Time to Achieve Testosterone Concentrations < 50 ng/dL(30 days after last dose)
- Serum testosterone concentrations(30 days after last dose)
- Time of maximum observed plasma concentration (Tmax) of SHR7280(30 days after last dose)
- Observed trough plasma concentration (Ctrough) of SHR7280(30 days after last dose)
- Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR7280(30 days after last dose)
- Serum luteinizing hormone (LH) concentrations(30 days after last dose)
- Percentage of Participants With Effective Castration Rate Over 24 Weeks(Day 1 of Week 5 to Day 1 of Week 25)
- Percentage of Serum Prostate-Specific Antigen Concentration Change frome Baseline at the End of Weeks 4, 8, 12(Day 1 of Weeks 5, 9 and 13)
- Maximum observed plasma concentration (Cmax) of SHR7280(30 days after last dose)
- Time to Prostate-Specific Antigen Progression(30 days after last dose)
- Serum follicle stimulating hormone (FSH) concentrations(30 days after last dose)
- Percentage of Participants With Effective Castration Rate Over 48 Weeks(Day 1 of Week 5 to Day 1 of Week 49)
研究者
研究点 (1)
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