[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547872":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":53,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":26,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"HER2 Low Metastatic\u002FRecurrent Breast Cancer","EXPERIMENTAL","Enrolled Subjects will receive a 5.4 mg\u002Fkg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W",[13],"Drug: FDA022-BB05",{"label":15,"type":10,"description":11,"interventionNames":16},"HER2 Expressing Metastatic\u002FRecurrent Endometrial Cancer",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"HER2 Overexpressing\u002FMutant Metastatic\u002FRecurrent Solid tumor",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","FDA022-BB05","Monoclonal antibody-drug conjugate for injection",[15,9,18],null,[28],{"name":29,"affiliation":30,"role":31},"Jian Zhang, MD","Fudan University","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","021-64175590","85000","syner2000@163.com",[39],{"facility":40,"status":41,"city":42,"state":26,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","China","CN",{"type":46,"coordinates":47},"Point",[48,49],121.45806,31.22222,{"lat":49,"lon":48},[52],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100547872","phase-2-a-study-of-fda022-bb05-in-advancedmetastatic-solid-tumors-100547872",false,"NCT06413615","A Study of FDA022-BB05 in Advanced\u002FMetastatic Solid Tumors","A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of FDA022-BB05 in Patients with Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Subjects fully understand and voluntarily participate in this study and sign informed consent.\n\nLeft Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to first dose.\n\nEastern Cooperative Oncology Group performance status( PS) of 0 or 1. Life expectancy ≥ 3 months.\n\nHistopathologically or cytologically confirmed advanced\u002Funresectable or metastatic solid malignant tumors that is refractory to or intolerable with standard treatment, or for which no standard treatment is available:\n\nCohort A: Pathologically documented breast cancer that:\n\n* Is unresectable or metastatic.\n* Has a history of low HER2 expression, defined as IHC 2+\u002FISH- or IHC 1+ (ISH- or untested).\n* For HR-positive participants, is documented refractory to endocrine therapy, defined as having progressed on at least 1 endocrine therapy and determined by the investigator that subject would no longer benefit from further treatment from endocrine therapy.\n* Was never previously HER2-positive(IHC 3+ or IHC 2+\u002FISH+) on prior pathology testing or was historically HER2 IHC 0 only.\n\nCohort B: Pathologically documented endometrial cancer that:\n\n* Is unresectable or metastatic.\n* Has a history of HER2 expression, defined as HER2 1+, 2+, or 3+ score on immunohistochemistry (IHC).\n* Have had at least one prior line of platinum-based therapy (in any setting).\n* Was never previously received other ADC anti-tumor treatment.\n\nCohort C: Metastatic or advanced solid tumor that are HER2 overexpression or mutation(Including urothelial cancer, colorectal adenocarcinoma and non-small cell lung cancer).\n\nExclusion Criteria:\n\n* A treatment history of antibody-drug conjugate containing topoisomerase I inhibitors.\n\nSubjects with one of the following conditions prior to first dose, including, but not limiting to：A major operation or severe trauma history within 4 weeks; A history of chemotherapy, targeted therapy, anti-angiogenesis therapy, biotherapy, immunotherapy, radiotherapy or other anti-tumor therapy within 4 weeks; A history of endocrine therapy within 3 weeks; A history of autologous stem cell transplant within 3 months.\n\nSubjects with other malignant tumors in the past three years (not including cured non-melanoma skin basal cell carcinoma, cervical carcinoma in situ and other malignancies of low malignant potential that have been effectively controlled without treatment).\n\nSubjects with symptomatic CNS metastasis (for example, cerebral edema requiring glucocorticoids therapy, or progressive CNS metastasis), not including prior cerebral and meningeal metastasis that is confirmed stable with MRI and without systematic glucocorticoids therapy.\n\nAdverse reactions from the previous anti-tumor treatment have not yet recovered (\\>Grade 2 in NCI-CTCAE 5.0, with exception of alopecia and pigmentation or other adverse reactions judged no safety risk by the investigator).\n\nSubjects with clinically significant cardiovascular or cerebrovascular disease, including, but not limiting to:\n\na medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.\n\na medical history of myocardial infarction or unstable angina within 6 months prior to screening; a QTc prolongation to \\> 450 millisecond (ms) in males and \\> 470 ms in females.\n\nSubjects with a medical history of interstitial lung disease (ILD)\u002Fpneumonia in need of glucocorticoids intervention，or with interstitial lung disease, or suspicious ILD by imaging detection at screening.\n\nSubjects with any uncontrolled active infection within 1 week prior to first dose.\n\nSubjects with concomitant disease potentially increasing toxicological risk. Known allergy to protein preparation or any protein drug with similar structure to FDA022-BB05.\n\nSubjects with a History of alcohol abuse or psychotropic\u002Fnarcotic drug abuse; Pregnant or lactating women. Subjects with poor compliance, or not suitable for this study as determined by the investigator due to other reasons.","ALL","18 Years","75 Years",{"count":66,"type":67},150,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing\u002Fexpressing solid tumors which are not eligible for curative therapy.",[73],"Advanced Solid Tumor","2024-09-24",{"date":76,"type":77},"2024-09-26","ACTUAL",{"date":79,"type":77},"2024-05-13",{"date":81,"type":67},"2026-06-30",{"name":5,"class":6},1]