Her 2 Positive Breast Cancer
Conditions
Brief summary
Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
Detailed description
This study will evaluate the efficacy of A166 in patients with HER2-positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates. A166 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
Interventions
DRUGA166
intravenous(IV) infusion (Q3W)
Sponsors
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form. 2. Breast cancer patients by histopathology and/or cytology documented. 3. In the advanced or metastatic stage, having received no more than 5 lines of systemic therapy, one of which must include a HER2 ADC with a topoisomerase inhibitor payload. 4. Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization. 5. At least one measurable lesion according to RECIST 1.1 criteria.
Exclusion criteria
1. Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload. 2. Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 or their components. 3. Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments. 4. Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses. 5. Presence of spinal cord compression or clinically active central nervous system (CNS) metastases. 6. Other conditions considered by the investigator to make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | Within 24 months of last patient enrolled | ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by investigator per RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Within 24 months of last patient enrolled | PFS, 6-month PFS, 12-month PFS.PFS as assessed by investigator according to RECIST v 1.1 |
| Overall survival (OS) | Within 48 months of last patient enrolled | OS, 1-year survival rate, 1.5-year survival rate, and 2-year survival rate.OS defined as time from inclusion until death |
| Disease control rate(DCR) | Within 24 months of last patient enrolled | DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by investigator per RECIST 1.1 |
| Duration of response(DOR) | Within 24 months of last patient enrolled | DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by investigator or death due to any cause, whichever occurs first. |
| Clinical Benefit Rate (CBR) | Within 24 months of last patient enrolled | CBR is defined as a patient having a best overall response of a complete response (CR), partial response (PR), or stable disease for at least 6 months. |
Countries
China
Contacts
CONTACTMin Yan, Professor
Outcome results
None listed