Back to resultsA Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-A1811 for injection ; capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Women aged 18 to 75 (inclusive). HER2 low expression unresectable or metastatic breast cancer confirmed by histology or cytology. ECOG score is 0 or 1. An expected survival of ≥ 12 weeks. At least one measurable lesion according to RECIST v1.1 criteria. Women of childbearing potential (WOCBP) subjects must agree to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding. Patients voluntarily joined the study and signed informed consent, had good compliance and willingness to cooperate with the visit and study related procedures. Exclusion Criteria: Have other malignancies within the past 5 years. Presence with uncontrollable third space effusion. Have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drug clinical studies within 4 weeks before the first medication. Accepted antibody drug conjugates containing etoisomercan derivative topoisomerase I inhibitor. Clinically significant cardiovascular disorders. Presence of active hepatitis B, hepatitis C, cirrhosis,or serious infected persons requiring antibiotic, antiviral or antifungal control. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I. Known to be allergic to any study drug or any of its excipients, or to humanized monoclonal antibody products. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption. Presence of other serious physical or mental diseases or laboratory abnormalities.
Sites / Locations
- The Second Hospital of Anhui Medical University
- Cancer Hospital Chinese Academy of Medical SciencesRecruiting
- Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
- Shantou Central Hospital
- Henan Provincial People's HospitalRecruiting
- The First Affiliated Hospital with Nanjing Medical University
- The First Hospital of China Medical University
- Shandong Cancer Hospital&Institute
- Wenzhou People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR-A1811 combined with capecitabine
Arm Description
Outcomes
Primary Outcome Measures
DLT（Phase I (dose exploration phase) ） [ Time Frame: 21 days after the first administration of each subject ]
Incidence of AEs（Phase I (dose exploration phase) ）
Incidence of SAEs（Phase I (dose exploration phase) ）
Objective response rate（Phase II (efficacy expansion phase)）
Secondary Outcome Measures
Duration of response(DoR )
Progression Free Survival(PFS)
Objective response rate（Phase I (dose exploration phase)）
Incidence of AEs（Phase II (efficacy expansion phase)）
Incidence of SAEs（Phase II (efficacy expansion phase)）
Full Information
NCT ID
NCT05845138
First Posted
April 18, 2023
Last Updated
July 27, 2023
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05845138
Brief Title
A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
Official Title
An Open-Label, Multi-center Phase Ⅰb/Ⅱ Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
SHR-A1811 combined with capecitabine
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-A1811 combined with capecitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-A1811 for injection ; capecitabine
Intervention Description
SHR-A1811 for injection; Capecitabine tablets
Primary Outcome Measure Information:
Title
DLT（Phase I (dose exploration phase) ） [ Time Frame: 21 days after the first administration of each subject ]
Time Frame
21 days after the first administration of each subject ]
Title
Incidence of AEs（Phase I (dose exploration phase) ）
Time Frame
from Day1 to 40 days after last dose
Title
Incidence of SAEs（Phase I (dose exploration phase) ）
Time Frame
from Day1 to 40 days after last dose
Title
Objective response rate（Phase II (efficacy expansion phase)）
Time Frame
One year after the last subject was enrolled in the group
Secondary Outcome Measure Information:
Title
Duration of response(DoR )
Time Frame
One year after the last subject was enrolled in the group
Title
Progression Free Survival(PFS)
Time Frame
One year after the last subject was enrolled in the group
Title
Objective response rate（Phase I (dose exploration phase)）
Time Frame
One year after the last subject was enrolled in the group
Title
Incidence of AEs（Phase II (efficacy expansion phase)）
Time Frame
from Day1 to 40 days after last dose
Title
Incidence of SAEs（Phase II (efficacy expansion phase)）
Time Frame
from Day1 to 40 days after last dose
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged 18 to 75 (inclusive).
HER2 low expression unresectable or metastatic breast cancer confirmed by histology or cytology.
ECOG score is 0 or 1.
An expected survival of ≥ 12 weeks.
At least one measurable lesion according to RECIST v1.1 criteria.
Women of childbearing potential (WOCBP) subjects must agree to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding.
Patients voluntarily joined the study and signed informed consent, had good compliance and willingness to cooperate with the visit and study related procedures.
Exclusion Criteria:
Have other malignancies within the past 5 years.
Presence with uncontrollable third space effusion.
Have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drug clinical studies within 4 weeks before the first medication.
Accepted antibody drug conjugates containing etoisomercan derivative topoisomerase I inhibitor.
Clinically significant cardiovascular disorders.
Presence of active hepatitis B, hepatitis C, cirrhosis,or serious infected persons requiring antibiotic, antiviral or antifungal control.
The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I.
Known to be allergic to any study drug or any of its excipients, or to humanized monoclonal antibody products.
Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption.
Presence of other serious physical or mental diseases or laboratory abnormalities.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuchao Wu
Phone
+0518-81220121
Email
shuchao.wu@hengrui.com
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fanfan Li
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijng
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Ma
Facility Name
Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinguo Mo
Facility Name
Shantou Central Hospital
City
Shantou
State/Province
Guangzhou
ZIP/Postal Code
515000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyong Wu
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilei Si
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongmei Yin
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuee Teng
Facility Name
Shandong Cancer Hospital&Institute
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huihui Li
Facility Name
Wenzhou People's Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miaoyong Zhu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
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