Clinical trial NCT05103826: A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: ER+ / HER2- Advanced Breast Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-02
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Female subjects aged 18 to 75 years old；
2. ECOG performance status 0-1;
3. Life expectancy is not less than 12 weeks;
4. Histological or cytological confirmation of ER+/HER2- recurrent/metastatic breast cancer;
5. 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;
6. Adequate function of major organs;
7. Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.

Exclusion Criteria:

1. Confirmed diagnosis of HER2 positive disease;
2. Participants who previously received SHR6390 or VEGFR inhibitors;
3. Allergy to study drug or its components;
4. Participated in other drug clinical trials within 4 weeks before the first dose;
5. 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;
6. 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；
7. Tumor has invaded important blood vessels or the tumor is likely to invade important blood vessels and cause fatal hemorrhage during treatment;
8. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein \>1.0g;
9. Active HBV/HCV/HIV infection;
10. The investigators determined that other conditions were inappropriate for participation in this clinical trial；
11. Pregnant or breast-feeding women;
12. Central nervous system (CNS) invasion.

Primary outcomes:
measure: (Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle
timeFrame: up to 28 days
measure: (Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib
timeFrame: up to 28 days
Secondary outcomes:
measure: AEs+SAEs
timeFrame: up to 24 months
measure: Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax
timeFrame: 6 months
measure: Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax
timeFrame: 6 months
measure: Evaluation of pharmacokinetic parameter of SHR6390+famitinib: t1/2
timeFrame: 6 months
measure: Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC
timeFrame: 6 months
measure: Evaluation of pharmacokinetic parameter of SHR6390+famitinib: CL/F
timeFrame: 6 months
measure: Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F
timeFrame: 6 months
measure: Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac
timeFrame: 6 months
measure: Objective Response Rate (ORR)
timeFrame: up to 24 months
measure: Disease control rate (DCR)
timeFrame: up to 24 months
measure: Duration of response (DoR)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
Study officials:
References: