HER2-positive metastatic breast cancer
Conditions
Interventions
Experimental group:All subjects were treated with ARX788 at a dose of 2.2mg/kg Q6W and continued until disease progression, intolerable toxicity, withdrawal from the study, or the end of this trial.
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old (including upper and lower limits), male or female; 2. Has a cytological or histological diagnosis of breast cancer (BC), with unresectable locally advanced, recurrent or metastatic BC; 3. Has previously received = 9 weeks, with disease recurrence or progression during treatment or within 12 months after the end of treatment; b) Recurrent or metastatic disease treated with at least one treatment regimen containing trastuzumab (or marketed trastuzumab biosimilars) +/- pertuzumab, with disease progression during or after treatment. 5. Has previously received treatment with taxane; 6. Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+), and historical data are acceptable based on the assessment of the Investigator; 7. Previously not received ARX788 treatment; 8. Has at least one measurable target lesion as per RECIST1.1 criteria with the following requirements: longest diameter of non-lymph nodes >= 10 mm and the shortest diameter of lymph nodes >= 15 mm(lesions that have been radiotreated or treated in other locoregional areas are not considered measurable lesions); 9. ECOG Performance Status Score of 0-1; 10. Has recovered from any AE (= 1.5 × 10^9/L; ii. Platelet >= 75 × 10^9/L; iii. Hemoglobin >= 80 g/L; b) Liver function: i. Bilirubin total = 60 mL/min; d) Coagulation: International normalized ratio (INR) = 3 months. 13. Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.
Exclusion criteria
Exclusion criteria: 1. Has known history to be allergic to any active ingredient or excipient of ARX788; a clear history of allergy to protein drugs; or has experienced other serious allergic reactions and is not suitable for treatment with ARX788 as determined by the Investigator; 2. Suffered from another malignant tumor in the past 5 years, except for carcinoma in situ, basal cell carcinoma, cutaneous squamous-cell carcinoma, papillary thyroid carcinoma, or follicular thyroid carcinoma that has received curative treatment; 3. With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy (including steroids, anticonvulsants, etc.) to control metastatic symptoms within 1 month prior to the first administration of the investigational product, except that patients who have stable clinical symptoms with limited brain metastases lesions are allowed to be enrolled; 4. Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment and is unsuitable to be enrolled based on the assessment of the Investigator; 5. Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease; 6. Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection; 7. Is unwilling or unable to stop wearing corneal contact lens during the trial; 8. Has cardiac insufficiency, including but not limited to those left ventricular ejection fraction (LVEF) = grade III.), and those with QT interval (QTc) prolongation in the 12-lead ECG examination (female> 470 ms; Male >450 ms); 9. Uncontrolled hypertension (at rest: systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg); 10. Has evidence of severe or uncontrollable systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as determined by the Investigator; 11. Has a history of immunodeficiency, including a positive HIV test, or has other acquired or congenital immunodeficiency disorders, or has a history of organ transplantation; 12. Is positive for hepatitis B surface antigen and HBV DNA >= 1000, or positive for hepatitis C virus antibody or treponema pallidum antibody; 13. Experiences major surgical treatment or severe traumatic injury within 2 weeks before the first use of the investigational product or plans to receive major surgical treatment during the trial; 14. Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial, including but not limited to novel coronavirus (2019-Cov), measles, mumps, rubella, chickenpox, yellow fever, rabies, Bacillus calmette-de-Carin (BCG) and typhoid vaccine, etc; 15. Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial; 16. Has received any systemic anti-tumor therapy (with the exception of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of response;Progression-free survival;Overall survival;Safety and tolerability;Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactMin Yan
He'nan Cancer Hospital
Outcome results
None listed