NCT05103826终止1 期
A Phase I Study to Evaluate Safety 、Tolerability 、 Pharmacokinetics and Efficacy of SHR6390 in Combination With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- (Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib
研究概览
简要总结
The study is being conducted to assess the safety 、tolerability 、 pharmacokinetics and efficacy of SHR6390 combined with famitinib in the treatment of ER + / HER2- advanced breast 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged 18 to 75 years old；
- •ECOG performance status 0-1;
- •Life expectancy is not less than 12 weeks;
- •Histological or cytological confirmation of ER+/HER2- recurrent/metastatic breast cancer;
- •Participants with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST1.1;
- •Adequate function of major organs;
- •Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.
排除标准
- •Confirmed diagnosis of HER2 positive disease;
- •Participants who previously received SHR6390 or VEGFR inhibitors;
- •Allergy to study drug or its components;
- •Participated in other drug clinical trials within 4 weeks before the first dose;
- •Other malignancies within 3 years, except cured non-melanoma skin cancer , skin basal cell carcinoma and squamous-cell carcinoma or carcinoma in situ of the cervix;
- •Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention；
- •Tumor has invaded important blood vessels or the tumor is likely to invade important blood vessels and cause fatal hemorrhage during treatment;
- •Urine routine test indicates urine protein ≥(++), or 24-hour urine protein >1.0g;
- •Active HBV/HCV/HIV infection;
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial；
- •Pregnant or breast-feeding women;
- •Central nervous system (CNS) invasion.
研究组 & 干预措施
SHR6390+famitinib
Experimental
Participants will receive SHR6390 in combination with famitinib.
干预措施: SHR6390、Famitinib (Drug)
结局指标
主要结局
(Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib
时间窗: up to 28 days
(Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle
时间窗: up to 28 days
次要结局
- Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F(6 months)
- Objective Response Rate (ORR)(up to 24 months)
- Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac(6 months)
- Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax(6 months)
- Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax(6 months)
- Disease control rate (DCR)(up to 24 months)
- AEs+SAEs(up to 24 months)
- Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC(6 months)
- Evaluation of pharmacokinetic parameter of SHR6390+famitinib: t1/2(6 months)
- Evaluation of pharmacokinetic parameter of SHR6390+famitinib: CL/F(6 months)
- Duration of response (DoR)(up to 24 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of PatientsAdvanced Malignant TumorsNCT05198817Suzhou Suncadia Biopharmaceuticals Co., Ltd.240
招募中
1 期
The Study of ICP-248 in Patients With Mature B-cell MalignanciesHematological MalignanciesNCT05728658Beijing InnoCare Pharma Tech Co., Ltd.191
招募中
1 期
Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis BChronic Hepatitis BNCT05808374Fujian Shengdi Pharmaceutical Co., Ltd.85
招募中
1 期
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.AnemiaNCT05773586Ascentage Pharma Group Inc.105
已完成
1 期
A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors.TumorNCT05203601Shanghai Institute Of Biological Products36