A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: ER+ / HER2- Advanced Breast Cancer
• Intervention / Treatment: Drug: SHR6390、Famitinib

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR6390+famitinib; Participants will receive SHR6390 in combination with famitinib.	Drug: SHR6390、Famitinib; SHR6390, oral;Famitinib, oral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle	up to 28 days
(Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs+SAEs	from the first drug administration to within 30 days for the last treatment dose	up to 24 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax		6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax		6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: t1/2		6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC		6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: CL/F		6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F		6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac		6 months
Objective Response Rate (ORR)	Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI	up to 24 months
Disease control rate (DCR)	Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1	up to 24 months
Duration of response (DoR)	Time from documentation of tumor response to disease progression assessed among patients who had an objective response	up to 24 months

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SHR6390-SHR1020-I-101-BC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No