NCT06568094招募中1 期
An Open, Multicenter Phase Ib/II Study on the Safety, Tolerability and Efficacy of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
适应症
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
- 100
- 试验地点
- 3
- 主要终点
- PSA response rate (Phase II)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have the ability to give informed consent, and are willing and able to comply with planned visits for medical examinations and other procedural requirements.
- •The age is above 18 years old when signing the informed consent (the ceiling age is 80 years old in the dose escalation phase), male.
- •ECOG score is 0 or
- •An expected survival of ≥ 12 weeks.
- •Adenocarcinoma of the prostate confirmed with histologically or cytologically ,and without a diagnosis of neuroendocrine or small cell carcinoma.
- •Adequate blood samples should be provided for gene mutation detection during the screening period. It is recommended to provide tumor tissue samples.
- •Male subjects whose partner is women of childbearing potential (WOCBP) are required to use highly effective contraception from the date of signing the informed consent until 3 months after the last dose of the investigational drug.
排除标准
- •Plan to receive any other antitumor therapy during this study.
- •Had history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); Or had other malignancies in the 5 years prior to the first dose.
- •Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter.
- •Had undergone major surgery within 28 days prior to first dosing; Minor traumatic surgery within 7 days prior to first dosing; There are non-healing wounds, untreated fractures.
- •Drugs with a strong inducer or inhibitor of the metabolic enzyme CYP3A have been used in the past, and the washout period from the end time to the first administration in this study is shorter than the 5 half-life of the drug.
- •The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I.
- •Central nervous system or meningeal metastasis of tumors is known or subjects have a history of primary central nervous system tumors.
- •Severe cerebrovascular disease occurred within 6 months prior to administration.
- •Subjects with poorly controlled hypertension and a history of hypertensive crisis or hypertensive encephalopathy.
- •Severe bone injury due to bone metastases, pathological fractures , and spinal cord compression as determined by the investigators at important sites that occurred within the last 6 months or are expected to occur in the near future.
- •Having one of multiple factors that affect the oral drug or having an active gastrointestinal disease or other disease that may significantly affect drug absorption, distribution, metabolism, or excretion.
- •Had history of allergy to the proposed investigational drug or its excipient components.
- •Presence of active heart disease in the 6 months prior to first dosing, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and medically treatable ventricular arrhythmias.
- •Presence of active hepatitis B and hepatitis C; Or serious infected persons requiring antibiotics, antivirals or antifungal drugs to control.
- •Presence of the history of immunodeficiency or organ transplantation.
- •Presence of other serious physical or mental diseases or laboratory abnormalities.
研究组 & 干预措施
HRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets
Experimental
干预措施: Prednisone Acetate tablets (Drug)
HRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets
Experimental
干预措施: Docetaxel Injection (Drug)
HRS-5041 tablets combined with SHR2554 tablets
Experimental
干预措施: HRS-5041 tablets (Drug)
HRS-5041 tablets combined with HRS-1167 tablets
Experimental
干预措施: HRS-1167 tablets (Drug)
HRS-5041 tablets combined with HRS-2189 tablets
Experimental
干预措施: HRS-5041 tablets (Drug)
HRS-5041 tablets combined with HRS-2189 tablets
Experimental
干预措施: HRS-2189 Tablets (Drug)
HRS-5041 tablets combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
Experimental
干预措施: HRS-5041 tablets (Drug)
HRS-5041 tablets combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
Experimental
干预措施: Abiraterone Acetate tablets（II） (Drug)
HRS-5041 tablets combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
Experimental
干预措施: Prednisone Acetate tablets (Drug)
HRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets
Experimental
干预措施: HRS-5041 tablets (Drug)
HRS-5041 tablets combined with HRS-1167 tablets
Experimental
干预措施: HRS-5041 tablets (Drug)
HRS-5041 tablets combined with SHR2554 tablets
Experimental
干预措施: SHR2554 tablets (Drug)
HRS-5041 tablets combined with HRS-6208 capsules
Experimental
干预措施: HRS-5041 tablets (Drug)
HRS-5041 tablets combined with HRS-6208 capsules
Experimental
干预措施: HRS-6208 capsules (Drug)
HRS-6208 capsules combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
Experimental
干预措施: HRS-6208 capsules (Drug)
HRS-6208 capsules combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
Experimental
干预措施: Abiraterone Acetate tablets（II） (Drug)
HRS-6208 capsules combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
Experimental
干预措施: Prednisone Acetate tablets (Drug)
结局指标
主要结局
PSA response rate (Phase II)
时间窗: 1 year
Recommended phase II dose (Phase Ib)
时间窗: 21 or 28 days
Incidence and severity of adverse events (AE) (Phase Ib)
时间窗: 2 years
次要结局
- Objective response rate (ORR)(1 year)
- Disease control rate (DCR)(1 year)
- Duration of response (DoR)(1 year)
- PSA response rate(1 year)
- Time to PSA progression(1 year)
- Radiographic progression-free survival (rPFS)(1 year)
- Overall survival (OS)(2 years)
- Blood concentrations of HRS-2189 (Phase Ib)(16 weeks)
- Objective response rate (ORR)(1 year)
- Disease control rate (DCR)(1 year)
- Duration of response (DoR)(1 year)
- PSA response rate(1 year)
- Time to PSA progression(1 year)
- Radiographic progression-free survival (rPFS)(1 year)
- Overall survival (OS)(2 years)
- Blood concentrations of HRS-5041(Phase Ib)(16 weeks)
- Blood concentrations of HRS-1167(Phase Ib)(16 weeks)
- Blood concentrations of SHR2554(Phase Ib)(16 weeks)
- Blood concentrations of Abiraterone (Phase Ib)(16 weeks)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D MutationAdvanced KRAS G12D Mutant Solid TumorsNCT06385678Jiangsu HengRui Medicine Co., Ltd.47
Unknown
1 期
A Trial to Evaluate the Safety and PK Profile of HRS4800 in Healthy SubjectsPainNCT04862884Jiangsu HengRui Medicine Co., Ltd.50
已完成
2 期
A Trial of HRS-5965 Tablets in Primary IgA NephropathyPrimary IgA NephropathyNCT06137768Chengdu Suncadia Medicine Co., Ltd.123
招募中
1 期
Exploratory Clinical Study of HRS-4642 Combined With Adebrelimab in the Treatment of Advanced Pancreatic Ductal AdenocarcinomaPancreatic CancerNCT06427239Fudan University130
已完成
2 期
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With Advanced HCC(RESCUE)Hepatocellular CarcinomaNCT03463876Jiangsu HengRui Medicine Co., Ltd.190