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 enrollmentJuly 25, 2023

ConditionsBreast Cancer

InterventionsSHR-A1811 for injection ; capecitabine

DrugsSHR-A1811 for injection ; capecitabine

Overview

Phase: Phase 1
Intervention: SHR-A1811 for injection ; capecitabine
Conditions: Breast Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 116
Locations: 9
Primary Endpoint: DLT（Phase I (dose exploration phase) ） [ Time Frame: 21 days after the first administration of each subject ]
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 25, 2023

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

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
•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

Intervention: SHR-A1811 for injection ; capecitabine

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)