Clinical trial NCT05845138: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SHR-A1811 combined with capecitabine
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: DLT（Phase I (dose exploration phase) ） [ Time Frame: 21 days after the first administration of each subject ]
timeFrame: 21 days after the first administration of each subject ]
measure: Incidence of AEs（Phase I (dose exploration phase) ）
timeFrame: from Day1 to 40 days after last dose
measure: Incidence of SAEs（Phase I (dose exploration phase) ）
timeFrame: from Day1 to 40 days after last dose
measure: Objective response rate（Phase II (efficacy expansion phase)）
timeFrame: One year after the last subject was enrolled in the group
Secondary outcomes:
measure: Duration of response(DoR )
timeFrame: One year after the last subject was enrolled in the group
measure: Progression Free Survival(PFS)
timeFrame: One year after the last subject was enrolled in the group
measure: Objective response rate（Phase I (dose exploration phase)）
timeFrame: One year after the last subject was enrolled in the group
measure: Incidence of AEs（Phase II (efficacy expansion phase)）
timeFrame: from Day1 to 40 days after last dose
measure: Incidence of SAEs（Phase II (efficacy expansion phase)）
timeFrame: from Day1 to 40 days after last dose
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijng
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
state: Guangxi
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangzhou
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital&Institute
state: Shandong
city: Wenzhou
country: China
facility: Wenzhou People's Hospital
state: Zhejiang
Study officials:
References: