NCT06689163招募中1 期
An Open, Multicenter Phase Ib/II Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and Prednisone
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
- 66
- 试验地点
- 2
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
The purpose of this study was to observe and evaluate the tolerability, safety, and pharmacokinetics of HRS-1167 combined with abiraterone acetate tablets (II) and prednisone in patients with metastatic prostate cancer, determine the RP2D, and evaluate the effectiveness.
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
- •Voluntary participation in this study, signed informed consent, compliance is good, and are willing and able to comply with planned visits.
- •The age is above 18 years old, male.
- •Adenocarcinoma of the prostate confirmed with histologically or cytologically.
- •Metastatic lesions were confirmed by CT/MRI or radionuclide bone scan (99mTc).
- •ECOG score is 0 or
- •An expected survival of ≥ 12 weeks.
- •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 120 days after the last dose of the investigational drug.
排除标准
- •Received systemic antitumor therapy 4 weeks before starting study treatment; 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; Patients who had previously received anti-tumor proprietary Chinese medicine could be enrolled if the interval between the end of treatment and the first study was not less than 2 weeks.
- •Subjects had prior or co-existing malignancies , except for cured basal cell carcinoma of the skin, papillary carcinoma of the thyroid, and other malignancies that had been adequately treated and cured for ≥ 3 years prior to the first dose with evidence of no recurrence or metastasis.
- •Subjects had cancerous meningitis or untreated central nervous system metastases.
- •Imaging showed that the tumor invaded large blood vessels or had unclear boundary with blood vessels. Or patients whose tumors are judged by the investigators to be at high risk of invading vital blood vessels during treatment and causing fatal bleeding.
- •Patients with clinical symptoms of cancerous ascites and pleural effusion requiring puncture and drainage; Or received ascites, pleural effusion drainage within 14 days before the first dose.
- •Severe bone injury due to tumor bone metastasis, including poorly controlled severe bone pain, pathological bone fractures and spinal cord compression that occurred within the last 6 months or are likely to occur in the near future.
- •Pneumonia with past or current interstitial pneumonia/interstitial lung disease requiring treatment with the glucocorticoid system; Patients with active pneumonia or severe impairment of lung function confirmed by pulmonary function examination.
- •Systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to the first dose.
- •Those with active pulmonary tuberculosis; Patients who had been adequately treated and had stopped anti-tuberculosis therapy for ≥3 months before the first dose could be enrolled.
- •Have high blood pressure that is not well controlled by antihypertensive medication; A history of hypertensive crisis or hypertensive encephalopathy.
- •Have clinical symptoms or diseases of the heart that are not well controlled.
- •Arterial/venous thrombosis events occurred within 6 months prior to the first dose.
- •Inability to swallow pills normally, or gastrointestinal dysfunction, may affect drug absorption.
- •Subjects who had a severe infection within 1 month prior to the first dose.
- •A known history of human immunodeficiency virus positive; Known to have active hepatitis.
- •The toxicity caused by previous antitumor therapy has not recovered to ≤ grade
- •Live vaccine was administered within 4 weeks prior to the first dose or possibly using during the study.
- •In the judgment of the investigator, there are other factors that may affect the results of the study or cause the study to be terminated.
研究组 & 干预措施
HRS-1167 combined with abiraterone acetate tablets (II) and prednisone
Experimental
干预措施: HRS-1167 tablets (Drug)
HRS-1167 combined with abiraterone acetate tablets (II) and prednisone
Experimental
干预措施: Abiraterone Acetate tablets（II） (Drug)
HRS-1167 combined with abiraterone acetate tablets (II) and prednisone
Experimental
干预措施: Prednisone Acetate tablets (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 28 days
Recommended phase II dose (RP2D)
时间窗: 28 days
The dose suspension rate caused by drug-related adverse events
时间窗: 2 years
The dose downregulation rate caused by drug-related adverse events
时间窗: 2 years
The dose termination rate caused by drug-related adverse events
时间窗: 2 years
次要结局
- PSA response rate(1 year)
- Time to PSA progression as assessed by the investigator(1 year)
- Duration of response (DoR)(1 year)
- Time to remission (TTR)(1 year)
- Objective response rate (ORR)(1 year)
- Disease control rate (DCR)(1 year)
- Steady-state peak concentration (Cmax,ss) of HRS-1167(16 weeks)
- Steady-state area under the concentration-time curve (AUCss)(16 weeks)
- Radiographic progression-free survival (rPFS)(1 year)
- 12-lead electrocardiogram(2 years)
- Overall survival (OS)(3 years)
- Adverse events(2 years)
- ECOG score(2 years)
- Steady-state valley concentration (Cmin,ss)(16 weeks)
- Steady-state peak time (Tmax,ss) of HRS-1167(16 weeks)
研究者
研究点 (2)
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