[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567097":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":11,"responsibleParty":25,"collaborators":11,"id":29,"slug":11,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":11,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":47,"overallStatus":50,"whyStopped":11,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":11},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ARX788","EXPERIMENTAL",null,[13],"Drug: ARX788",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","2.2 mg\u002Fkg IV infusion on Day 1 of each 42-day treatment cycle.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Min Yan","CONTACT","+86 15713857388","ym200678@126.com",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Min Yan, MD","Chief Physician","100567097",false,"NCT06663748","ARX788 in HER2-positive Metastatic Breast Cancer Patients","Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients with HER2-positive Advanced Breast Cancer","Inclusion Criteria:\n\n* 18 to 75 years old (including upper and lower limits), male or female;\n* Unresectable locally advanced, recurrent or metastatic BC;\n* Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC;\n* Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);\n* Has at least one measurable target lesion as per RECIST1.1 criteria;\n* Has recovered from any AE (≤ Grade 1) related to prior surgery and prior cancer treatment;\n* Adequate bone marrow, liver, kidney and coagulation function;\n* ECOG Performance Status Score of 0-1;\n* Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.\n\nExclusion Criteria:\n\n* Has known history to be allergic to any active ingredient or excipient of ARX788;\n* With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy;\n* Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment;\n* 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;\n* Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;\n* Has cardiac insufficiency;\n* Uncontrolled hypertension;\n* Has evidence of severe or uncontrollable systemic diseases;\n* Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial;\n* Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial;\n* Is unwilling or unable to stop wearing corneal contact lens during the trial;\n* Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;\n* Has any mental or cognitive disorder that may restrict his\u002Fher understanding and execution of the informed consent form;\n* Other conditions that the Investigator considers inappropriate for participation in this trial, such as poor compliance.","ALL","18 Years","75 Years",{"count":39,"type":40},44,"ESTIMATED","INTERVENTIONAL",[43],"PHASE2","A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.",[46],"HER2-positive, Metastatic Breast Cancer",[9,48,49],"HER2-positive breast cancer","Q6W","NOT_YET_RECRUITING","2024-10-27",{"date":53,"type":54},"2024-10-29","ACTUAL",{"date":56,"type":40},"2024-11-20",{"date":58,"type":40},"2029-11-20",{"name":5,"class":6}]