[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616758":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":21,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":21,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":21,"enrollmentInfo":63,"targetDuration":21,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group 1","EXPERIMENTAL","Cohort1:Patients with histologically confirmed extramammary Paget's disease (EMPD) demonstrating HER2 expression (IHC ≥ 1+) and having unresectable locally advanced or metastatic disease.\n\nCohort2: Patients with histologically confirmed locally advanced or metastatic rare solid tumors (such as sarcoma, urachal carcinoma, etc.) demonstrating HER2 expression (IHC ≥ 1+) , who have experienced disease progression on or after standard therapy, or for whom no standard therapy is available, and with at least one measurable lesion.\n\nCohort3:Patients with histologically confirmed locally advanced or metastatic urothelial carcinoma demonstrating HER2 expression (IHC ≥ 1+) , who have experienced disease progression following first-line treatment with a PD-1\u002FPD-L1 inhibitor in combination with Enfortumab Vedotin or Disitamab vedotin",[13,14],"Drug: SHR-A1811","Drug: Trastuzumab Rezetecan",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","SHR-A1811","Trastuzumab Rezetecan (SHR-A1811) is administered at a dose of 4.8 mg\u002Fkg every 21 days (q3w), constituting one treatment cycle.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Trastuzumab Rezetecan","Patients who have failed standard therapy are treated with Trastuzumab Rezetecan",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Sheng Zhang","CONTACT","+86 021-64175590","wozhangsheng@hotmail.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200030","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":21,"email":31},"Sheng ZHANG","021-64175590",{"type":52,"investigatorFullName":28,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Prof.","100616758","phase-2-trastuzumab-rezetecan-in-advanced-solid-tumors-refractory-to-standard-therapies-100616758",false,"NCT07309770","Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies","Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies: A Multicenter, Single-Arm, Phase II Study With Multiple Cohorts","Inclusion Criteria:\n\nVoluntarily sign a written informed consent form.\n\nAge ≥ 18 years.\n\nDiagnosed with the corresponding advanced tumor confirmed by histology and\u002For cytology, combined with imaging or ultrasound assessment, and pathologically confirmed as HER2-positive (i.e., HER2 ≥ 1+ by immunohistochemistry \\[IHC\\]).\n\nCohort 1 only: Histologically confirmed extramammary Paget's disease (EMPD) with unresectable locally advanced or metastatic disease.\n\nCohort 2 only: Histologically confirmed locally advanced or metastatic rare solid tumor (e.g., sarcoma, urachal cancer) refractory to standard treatment or for whom no standard treatment is available.\n\nCohort 3 only: Histologically confirmed locally advanced or metastatic urothelial carcinoma with disease progression following first-line treatment with a PD-1\u002FPD-L1 inhibitor combined with enfortumab vedotin or disitamab vedotin.\n\nECOG Performance Status: 0 to 2.\n\nAt least one measurable lesion (according to RECIST v1.1 criteria: non-nodal lesions with longest diameter ≥10 mm on CT scan, nodal lesions with short axis ≥15 mm on CT scan).\n\nHematological function:\n\nAbsolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL\n\nPlatelet count (PLT) ≥ 70 × 10⁹\u002FL\n\nHemoglobin (HGB) ≥ 80 g\u002FL\n\nHepatic function:\n\nSerum total bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN)\n\nAlanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if liver metastases are present)\n\nSerum albumin ≥ 28 g\u002FL\n\nRenal function:\n\nSerum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula)\n\nCoagulation function:\n\nInternational Normalized Ratio (INR) ≤ 1.5 and\u002For Prothrombin Time (PT) ≤ 1.5 × ULN\n\nActivated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN\n\nEstimated life expectancy ≥ 3 months.\n\nUse of medically approved contraception during the treatment period and for at least 120 days after the end of the study; sperm donation or cryopreservation for fertilization purposes is not allowed during this period.\n\nAbility to comply with the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from participation in this study:\n\nPresence of any severe and\u002For uncontrolled disease, including:\n\nPoorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL).\n\n≥ Grade 2 myocardial ischemia, myocardial infarction, arrhythmia (QTcF ≥ 470 ms), or ≥ Grade 2 congestive heart failure (New York Heart Association \\[NYHA\\] classification).\n\nActive or uncontrolled severe infection (≥ CTCAE Grade 2 infection) requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection.\n\nHistory of active tuberculosis.\n\nUncontrolled ascites, pericardial effusion, or pleural effusion requiring repeated drainage.\n\nActive hepatitis (liver enzyme levels not meeting inclusion criteria; for Hepatitis B: HBV DNA ≥ 2000 IU\u002Fml or ≥ 10⁴ copies\u002Fml; for Hepatitis C: HCV RNA ≥ 2000 IU\u002Fml or ≥ 10⁴ copies\u002Fml; carriers with chronic hepatitis B virus \\[HBV DNA \\\u003C 10⁴ IU\u002Fml\\] may be enrolled if they receive concomitant antiviral therapy during the trial).\n\nHistory of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases.\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\nKnown presence of brain metastases, leptomeningeal metastasis, spinal cord compression, or spinal metastasis.\n\nWithin 6 months prior to the first dose: history of esophageal\u002Fgastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, intestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding; extensive intestinal resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n\nPresence of non-healing or poorly healed wounds, active ulcers.\n\nToxicity from previous antineoplastic therapy that has not resolved to ≤ Grade 1 per NCI CTCAE v5.0 (except for alopecia).\n\nMajor surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or presence of long-term unhealed wounds or fractures.\n\nHistory of severe hypersensitivity reaction to monoclonal antibodies; known allergy to the active components or excipients of the study drug(s).\n\nParticipation in another clinical trial within 4 weeks prior to the start of the study.\n\nAdministration of a live vaccine within 30 days prior to the first dose, or planned administration during the study.\n\nHistory of severe allergy.\n\nBleeding tendency, coagulopathy, or undergoing thrombolytic therapy.\n\nHistory of drug abuse or inability to discontinue use, or history of psychiatric disorders.\n\nHistory of clear neurological or psychiatric disorders, such as dementia, epilepsy, or susceptibility to seizures.\n\nAny condition that, in the investigator's judgment, seriously endangers subject safety, affects subject completion of the study (e.g., severe diabetes, thyroid disease, psychosis), may compromise subject safety or the ability to provide informed consent (including abnormal laboratory findings), or involves psychological, familial, sociological, or geographical conditions that may preclude compliance with the study protocol and follow-up plan.\n\nAny other reason deemed by the investigator to make the subject unsuitable for participation in this clinical trial.","ALL","18 Years",{"count":64,"type":65},90,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This study is a single-center, multi-cohort, phase II clinical trial. Eligible patients with HER2-positive advanced solid tumors were enrolled after providing informed consent. A total of 90 patients were allocated into three cohorts (30 patients each): those with Extramammary Paget's Disease (EMPD), rare solid tumors, or urothelial carcinoma, who had experienced failure of standard treatment or for whom no standard treatment was available. The participant recruitment period was 12 months, and the follow-up duration was 12 months. All patients received Trastuzumab Rezetecan (SHR-A1811) at a dose of 4.8 mg\u002Fkg administered every three weeks (q3w). They were followed until disease progression, withdrawal from the study, loss to follow-up, or death, whichever occurred first. Tumor response was assessed radiologically every 6 weeks during treatment. Safety follow-up was conducted 30 days after the last dose, followed by survival follow-up every 3 months thereafter.",[71,72,73],"Urachal Cancer","Advanced Solid Tumor Cancer","Antibody-drug Conjugates",[75,76,77,78,23],"Antibody-Drug Conjugates","Rare tumor","Extra-mammary Paget disease","Urachal cancer","2025-12-15",{"date":81,"type":82},"2025-12-30","ACTUAL",{"date":84,"type":65},"2025-12-18",{"date":86,"type":65},"2028-03-11",{"name":28,"class":6},1]