A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
Phase 1
Terminated
- Conditions
- ER+ / HER2- Advanced Breast Cancer
- Interventions
- Drug: SHR6390、Famitinib
- Registration Number
- NCT05103826
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 3
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SHR6390+famitinib SHR6390、Famitinib Participants will receive SHR6390 in combination with famitinib.
- Primary Outcome Measures
Name Time Method (Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib up to 28 days (Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle up to 28 days
- Secondary Outcome Measures
Name Time Method Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F 6 months Objective Response Rate (ORR) up to 24 months Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax 6 months Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax 6 months AEs+SAEs up to 24 months from the first drug administration to within 30 days for the last treatment dose
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC 6 months Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac 6 months Disease control rate (DCR) up to 24 months Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
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 Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Trial Locations
- Locations (1)
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China