NCT06738745尚未招募2 期
A Phase II Study of HRS-2189 Combined HRS-5041 in Metastatic Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- PSA50
研究概览
简要总结
Our study is aimed to evaluate the efficacy and safety of HRS-2189 combined with HRS-5041 in metastatic 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 years to 80 years old (including boundary values), male subjects;
- •ECOG PS Score: 0~1;
- •Histologically or cytologically confirmed prostate adenocarcinoma, and no prior diagnosed as neuroendocrine carcinoma or small cell carcinoma;
- •Disease progression when enrolled in the study;
- •Confirmed metastatic disease by CT/MRI/99mTc radioactive bone scan;
- •Subjects must have a life expectancy ≥ 3 months;
- •Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
- •Male subjects who have partner of childbearing potential should agree to take action of contraception and avoid to donate sperm;
- •Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.
排除标准
- •Known existence of CNS metastasis or meningeal metastasis, or known history of primary CNS tumor;
- •Severe bone injury caused by bone metastasis identified by investigators, including uncontrolled severe bone pain, pathological bone fracture at the important part and spinal cord compression having occurred for the last 6 months or expected to occur in the near future;
- •Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;
- •Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy or attenuated live vaccine within 4 weeks before first dose of study therapy (6-week washout period for bicalutamide);
- •Has been enrolled in other clinical trials within 4 weeks before first dose of study therapy;
- •Use of other antitumor treatment during the study;
- •Damage caused by any prior anti-tumor treatment has not recovered to ≤ grade 1 or criteria specified by this study (per NCI-CTCAE 5.0; except alopecia or other tolerable adverse events identified by investigators);
- •Uncontrolled hypertension, or prior hypertensive crisis or history of hypertension;
- •Existence of arterial/venous thrombotic event within 6 months before first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral haemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
- •Existence of one of multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and bowel obstruction), or active gastrointestinal disease or other diseases which may obviously affect distribution of drug absorption, metabolism or excretion;
- •Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU/mL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;
- •Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia >38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);
- •Subjects with innate or acquired immunodeficiency (such as HIV infection); Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation;
- •Other malignancy within prior 3 years before first dose of study therapy, except curatively treated cancer, including radical therapy-treated skin basal cell carcinoma or skin squamous cell carcinoma, papillary thyroid carcinoma, or any type of in situ carcinoma with complete excision, such as in situ cancer of the cervix, ductal carcinoma in situ of breast;
- •Hypersensitivity to study therapy or any of its excipients;
- •Uncontrolled cardiovascular clinical symptom or disease within 6 months before first dose of study therapy;
- •Other conditions that might influence the study and analysis of results in the opinion of the investigator.
研究组 & 干预措施
HRS-2189 + HRS-5041
Experimental
All subjects enrolled will receive HRS-2189 + HRS-5041 combination therapy.
干预措施: HRS-2189 (Drug)
HRS-2189 + HRS-5041
Experimental
All subjects enrolled will receive HRS-2189 + HRS-5041 combination therapy.
干预措施: HRS-5041 (Drug)
结局指标
主要结局
PSA50
时间窗: up to 2 years
PSA50 is the percentage of evaluable patients with ≥50% decline in PSA level, measured at baseline and the time point of every 4 weeks in efficacy analysis set.
次要结局
- PSA30(up to 2 years)
- Time to PSA progression(up to 2 years)
- ORR by investigator(up to 2 years)
- DCR by investigator(up to 2 years)
- DoR(up to 2 years)
- rPFS(up to 2 years)
- Time to next skeletal-related event(up to 2 years)
- OS(up to 2 years)
- Percentage of participants who experience an adverse event [Safety and Tolerability](From the time of informed consent provided to 30 days after the last dose of study therapy)
研究者
Ding-Wei Ye
Chief physician
Fudan University
研究点 (1)
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