NCT06830850招募中1 期
A Phase I, Open-label, Multi-Center, Non-Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- Incidence and severity of adverse events, ECOG PS score, vital signs (pulse rate, respiratory rate, blood pressure, body temperature), ECG, clinical chemistry, hematology, urinalysis and physical examination
研究概览
简要总结
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant 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
- •IInclusion Criteria
- •Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- •Adequate bone marrow and other vital organ functions
- •Adequate liver function tests
- •Metastatic Castration-resistant Prostate Cancer
排除标准
- •Plan to receive any other anti-tumor therapy during the study.
- •Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.
- •Uncontrolled hypertension (systolic blood pressure [SBP] > 150 mmHg and/or diastolic blood pressure [DBP] > 100 mmHg with regular anti-hypertension therapy).
- •Factors that may affect the oral administration of the IP (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active gastrointestinal (GI) disease or other disease which may affect the absorption, distribution, metabolism, or elimination of IP.
- •Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
- •Active heart disease within 6 months prior to the first dosing of this study.
- •Medical history of other malignant tumor within 5 years prior to dosing.
- •Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.
研究组 & 干预措施
: HRS-5041 dose level 1
Experimental
240 mg BID
干预措施: HRS-5041 Single dose of HRS-5041 orally administered (Drug)
结局指标
主要结局
Incidence and severity of adverse events, ECOG PS score, vital signs (pulse rate, respiratory rate, blood pressure, body temperature), ECG, clinical chemistry, hematology, urinalysis and physical examination
时间窗: Screening up to study completion, an average of 1 year.
To evaluate the safety and tolerability profile of HRS-5041 in subjects with mCRPC.
次要结局
- Cmin,ss(From administration to C2, up to 4 months.)
- Concentration(Screening up to study completion,an average of 1 year.)
- Cmax,ss(From administration to C2, up to 4 months.)
- Objective Response Rate (ORR)(Screening up to study completion, an average of 2 years.)
- Best of Response (DoR)(Screening up to study completion, an average of 2 years.)
- Disease Control Rate (DCR)(Screening up to study completion, an average of 2 years.)
- rPFS (radiographic progression-free survival(Screening up to study completion, an average of 2 years.)
- PSA Response Rate at the end of Week 12(Screening up to the end of Week 12 , up to 4 months.)
- Proportion of Subjects with PSA50 (≥ 50% decline in serum PSA from baseline)(Screening up to the end of treatment, an average of 1 year.)
- Proportion of Subjects with PSA30 (≥ 30% decline in serum PSA from baseline)(Screening up to the end of treatment, an average of 1 year.)
- Time to PSA Progression(From the date of first drug administration to the date of first PSA progression, an average of 1 year.)
- Overall Survival (OS)(From the date of first drug administration to the date of death from any cause, an average of 2 year.)
研究者
研究点 (11)
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