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

NCT05103826 | Terminated Phase 1

• 1 other identifier: SHR6390-SHR1020-I-101-BC
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

ER+ / HER2- Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

• (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 Outcomes (11)

• AEs+SAEs

  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

Study Arms (1)

SHR6390+famitinib

EXPERIMENTAL

Participants will receive SHR6390 in combination with famitinib.

Drug: SHR6390、Famitinib

Interventions

SHR6390、Famitinib DRUG

SHR6390, oral;Famitinib, oral.

SHR6390+famitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: October 25, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

CN (1)