NCT07358377招募中1 期
An Open-Label, Multi-Center Phase II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Fulvestrant or Letrozole in Patients With Solid Tumor
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
- 15
- 试验地点
- 6
- 主要终点
- Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs),
研究概览
简要总结
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
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
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •HR-positive or HER2-negative solid tumor patients
排除标准
- •Plan to receive any other anti-tumor therapy during the study.
- •Active brain metastases .
- •Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure.
- •Previous use of fulvestrant
- •clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
- •With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease).
- •With acute or active tuberculosis infection requiring medication.
- •Pregnant or lactating women, or females planning to become pregnant During the study.
- •Known history of clinically significant liver disease, untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] or hepatitis B core antibody [HBcAb] positive
研究组 & 干预措施
HRS-6209 Capsules and fulvestrant injection
Experimental
干预措施: HRS-6209 Capsules and fulvestrant injection (Drug)
结局指标
主要结局
Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs),
时间窗: Screening up to study completion,, an average of 1 year.
To safety and tolerability of HRS-6209 in combination with fulvestrant in patients with advanced unresectable or metastatic breast cancer
次要结局
- Concentration(From administration to Cycle2 , up to 4 months.)
- Cmax,ss(From administration to Cycle2, up to 4 months.)
- Cmin,ss(From administration to Cycle2, 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.)
研究者
研究点 (6)
Loading locations...
相似试验
进行中（未招募）
2 期
Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute PancreatitisNCT07308392Fujian Shengdi Pharmaceutical Co., Ltd.119
进行中（未招募）
2 期
Phase II Clinical Study of HRS-9563 in Patients With Mild to Moderate HypertensionNCT07297797Fujian Shengdi Pharmaceutical Co., Ltd.238
招募中
1 期
A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee OsteoarthritisNCT07351968Shandong Suncadia Medicine Co., Ltd.200
招募中
1 期
A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney FunctionNCT07322016Shandong Suncadia Medicine Co., Ltd.36
进行中（未招募）
2 期
A Study of SHR-1819 in Patients With Moderate-to-severe Atopic DermatitisNCT07321951Guangdong Hengrui Pharmaceutical Co., Ltd201