Trial Title:
A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
NCT ID:
NCT05845138
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Capecitabine
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
SHR-A1811 combined with capecitabine
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811 for injection ; capecitabine
Description:
SHR-A1811 for injection; Capecitabine tablets
Arm group label:
SHR-A1811 combined with capecitabine
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Women aged 18 to 75 (inclusive).
2. HER2 low expression unresectable or metastatic breast cancer confirmed by histology
or cytology.
3. ECOG score is 0 or 1.
4. An expected survival of ≥ 12 weeks.
5. At least one measurable lesion according to RECIST v1.1 criteria.
6. 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.
7. 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:
1. Have other malignancies within the past 5 years.
2. Presence with uncontrollable third space effusion.
3. Have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular
targeted therapy, biological therapy or other drug clinical studies within 4 weeks
before the first medication.
4. Accepted antibody drug conjugates containing etoisomercan derivative topoisomerase I
inhibitor.
5. Clinically significant cardiovascular disorders.
6. Presence of active hepatitis B, hepatitis C, cirrhosis,or serious infected persons
requiring antibiotic, antiviral or antifungal control.
7. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I.
8. Known to be allergic to any study drug or any of its excipients, or to humanized
monoclonal antibody products.
9. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other
factors affecting drug administration and absorption.
10. Presence of other serious physical or mental diseases or laboratory abnormalities.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Fanfan Li
Email:
Principal Investigator
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Investigator:
Last name:
Fei Ma
Email:
Principal Investigator
Facility:
Name:
Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
Address:
City:
Nanning
Zip:
530000
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Qinguo Mo
Email:
Principal Investigator
Facility:
Name:
Shantou Central Hospital
Address:
City:
Shantou
Zip:
515000
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Zhiyong Wu
Email:
Principal Investigator
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Investigator:
Last name:
Pilei Si
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital with Nanjing Medical University
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Yongmei Yin
Email:
Principal Investigator
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Yuee Teng
Email:
Principal Investigator
Facility:
Name:
Shandong Cancer Hospital&Institute
Address:
City:
Jinan
Zip:
250000
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Huihui Li
Email:
Principal Investigator
Facility:
Name:
Wenzhou People's Hospital
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Miaoyong Zhu
Email:
Principal Investigator
Start date:
July 25, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05845138
