NCT05845138RecruitingPhase 1
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.
Suzhou Suncadia Biopharmaceuticals Co., Ltd.9 sites in 1 country116 target enrollmentStarted: July 25, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 116
- Locations
- 9
- Primary Endpoint
- DLT（Phase I (dose exploration phase) ） [ Time Frame: 21 days after the first administration of each subject ]
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
SHR-A1811 combined with capecitabine
Experimental
Intervention: SHR-A1811 for injection ; capecitabine (Drug)
Outcomes
Primary Outcomes
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 ]
Incidence of AEs（Phase I (dose exploration phase) ）
Time Frame: from Day1 to 40 days after last dose
Incidence of SAEs（Phase I (dose exploration phase) ）
Time Frame: from Day1 to 40 days after last dose
Objective response rate（Phase II (efficacy expansion phase)）
Time Frame: One year after the last subject was enrolled in the group
Secondary Outcomes
- 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)
Investigators
Study Sites (9)
Loading locations...
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