NCT03569280已完成1 期
A First-in-Human Study to Determine the Safety, Pharmacokinetics and Efficacy of KPG-121 When Administered With Enzalutamide, Abiraterone, or Apalutamide in Subjects With Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KPG-121
研究概览
简要总结
This is a Phase 1, open-label, multicenter study of KPG-121 administered orally once daily (QD) in 28-day treatment cycles to adult subjects.
详细描述
This Phase 1 study will comprise two parts: Part 1 will be a 3+3 dose escalation design to characterize the MTD and a RP2D, Part 2 will be an expansion cohort at RP2D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Signed informed consent provided prior to any study-related procedure being performed;
- •Able to swallow and retain orally administered medication;
- •Male aged 18 years and older;
- •diagnosis of prostate carcinoma;
- •Men with either non-metastatic or metastatic CRPC are eligible;
- •Completed at least 4 or more weeks of prior continuous therapy with fixed stable dose enzalutamide, abiraterone or apalutamide prior to initiating study treatment (for Part 1), or with fixed stable dose enzalutamide (for Part 2), with no change in dose for at least 2 weeks prior to screening;
- •Serum testosterone level <50 ng/dL (<0.5 ng/mL, <7.0 nmol/L).
- •ECOG performance status of 0 or 1;
- •Adequate baseline organ function;
- •Must have a QT interval corrected for heart rate according to Fridericia's formula (QTcF) <470 milliseconds (msec) or <480 msec with bundle branch block;
- •Male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of screening until 3 months after the last dose of study medication;
- •Willing and able to comply with all protocol required visits and assessments.
排除标准
- •Prior chemotherapy, radiation;
- •Prior malignancy other than CRPC.
- •Uncontrolled hypothyroidism, or TSH >2.0 x ULN at screening.
- •Current use of or anticipated requirement of prohibited medication(s);
- •Any unresolved ≥grade 2 (per CTCAE v5.0) toxicity from previous anti-cancer therapy;
- •Previous history of difficulty swallowing capsules;
- •Known active infection requiring intravenous (IV);
- •Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test ;
- •History of seizure or any condition that may predispose subject to seizure (e.g., prior cortical stroke or significant brain trauma). History of loss of consciousness or transient ischemic attack within 12 months prior to the start of study medication;
- •Poorly controlled hypertension;
- •Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
- •History or evidence of cardiovascular risk; known cardiac metastases;
- •Previous major surgery within 30 days prior to the start of study medication;
结局指标
主要结局
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KPG-121
时间窗: Cycle-1 (28-day)
MTD is one dose level below the dose level that results in ≥33% of subjects with a DLT
次要结局
- Incidence of Adverse Events [Safety and Tolerability](Up to Cycle-6 (28-day per cycle))
- Pharmacokinetic (PK) profile of KPG-121(Cycle-1 (up to 28-day))
研究者
研究点 (6)
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