A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
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.
1 other identifier
interventional
116
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 breast-cancer
Started Jul 2023
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 1, 2023
March 1, 2023
1.4 years
April 18, 2023
July 27, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
DLT（Phase I (dose exploration phase) ） [ Time Frame: 21 days after the first administration of each subject ]
21 days after the first administration of each subject ]
Incidence of AEs（Phase I (dose exploration phase) ）
from Day1 to 40 days after last dose
Incidence of SAEs（Phase I (dose exploration phase) ）
from Day1 to 40 days after last dose
Objective response rate（Phase II (efficacy expansion phase)）
One year after the last subject was enrolled in the group
Secondary Outcomes (5)
Duration of response(DoR )
One year after the last subject was enrolled in the group
Progression Free Survival(PFS)
One year after the last subject was enrolled in the group
Objective response rate（Phase I (dose exploration phase)）
One year after the last subject was enrolled in the group
Incidence of AEs（Phase II (efficacy expansion phase)）
from Day1 to 40 days after last dose
Incidence of SAEs（Phase II (efficacy expansion phase)）
from Day1 to 40 days after last dose
Study Arms (1)
SHR-A1811 combined with capecitabine
EXPERIMENTALInterventions
SHR-A1811 for injection; Capecitabine tablets
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijng, 100000, China
Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
Nanning, Guangxi, 530000, China
Shantou Central Hospital
Shantou, Guangzhou, 515000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110000, China
Shandong Cancer Hospital&Institute
Jinan, Shandong, 250000, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
April 18, 2023
First Posted
May 6, 2023
Study Start
July 25, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
August 1, 2023
Record last verified: 2023-03