[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652045":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":51,"collaborators":55,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":20,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":20,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":99,"whyStopped":20,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Single arm: Neoadjuvant pucotenlimab + becotatug vedotin, then adjuvant pucotenlimab for surgical patients.\n\nMax 4 neoadjuvant cycles (Q3W): Day1 pucotenlimab 3mg\u002Fkg (max 200mg, 60min IV), ≥30min later becotatug vedotin 2.0mg\u002Fkg (60-90min IV). Therapy stops early for progression\u002Funmanageable toxicity.\n\nPost-neoadjuvant MDT assessment for consolidative surgery. Resectable patients receive 17 cycles of adjuvant pucotenlimab 200mg Q3W.",[13],"Drug: Pucotenlimab plus Becotatug Vedotin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Pucotenlimab plus Becotatug Vedotin","Neoadjuvant PD-1 inhibitor pucotenlimab (HX008) combine with EGFR ADC becotatug vedotin (MRG003) for locally advanced penile squamous cell carcinoma. Up to 4 Q3W neoadjuvant cycles; surgical patients receive 17-cycle adjuvant pucotenlimab.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Hui Han, MD, PhD","CONTACT","+86-020-8734-3860","hanhui@sysucc.org.cn",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Longbin Xiong, MD","+86-020-8734-2318","xionglb@sysucc.org.cn",[32],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060","China","CN",{"type":40,"coordinates":41},"Point",[42,43],113.25,23.11667,{"lat":43,"lon":42},[46,48],{"name":47,"role":24,"phone":25,"phoneExt":20,"email":26},"Hui Han, Prof.",{"name":49,"role":24,"phone":50,"phoneExt":20,"email":30},"Longbin Xiong, Dr.","020-8734-2318",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","ZHOU FANGJIAN","M.D., Ph.D.",[56,58,60,62,64,67,69,71],{"name":57,"class":6},"The First Affiliated Hospital of Nanchang University",{"name":59,"class":6},"Jiangsu Cancer Institute & Hospital",{"name":61,"class":6},"Tianjin Medical University Cancer Institute and Hospital",{"name":63,"class":6},"Hunan Cancer Hospital",{"name":65,"class":66},"The Affiliated Tumor Hospital of Xinjiang Medical University","UNKNOWN",{"name":68,"class":6},"West China Hospital",{"name":70,"class":6},"Qilu Hospital of Shandong University",{"name":72,"class":6},"Tongji Hospital","100652045","phase-2-neoadjuvant-pucotenlimab-and-becotatug-vedotin-for-locally-advanced-penile-cancer-100652045",false,"NCT07767266","Neoadjuvant Pucotenlimab and Becotatug Vedotin for Locally Advanced Penile Cancer","Pucotenlimab (HX008) Combined With Becotatug Vedotin (MRG003) as Neoadjuvant Therapy for Locally Advanced Penile Squamous Cell Carcinoma：A Multicenter, Single-Arm, Phase II Clinical Trial","Inclusion Criteria:\n\n1. Aged 18-75 years, biologically male.\n2. Histologically confirmed penile squamous cell carcinoma, stage T4 any N M0 or any T N2-N3 M0 without distant metastasis.\n3. Treatment-naive; or relapsed patients with ≥12 months interval from last prior systemic therapy.\n4. At least one measurable target lesion per RECIST 1.1.\n5. ECOG performance status 0-2.\n6. Adequate bone marrow, liver and renal function as predefined lab thresholds.\n7. Expected survival ≥12 months.\n8. No severe uncontrolled organ dysfunction.\n9. Able to understand and voluntarily sign written informed consent.\n\nExclusion Criteria:\n\n1. Pre-existing grade ≥2 peripheral neuropathy interfering daily activities.\n2. Prior neoadjuvant therapy for penile cancer; previous use of PD-1\u002FPD-L1 inhibitors or EGFR ADCs including becotatug vedotin.\n3. Known hypersensitivity to pucotenlimab, becotatug vedotin or excipients.\n4. Active malignancy within 5 years (excluding cured basal cell skin carcinoma and low-risk prostate cancer).\n5. Uncontrolled severe cardiovascular disease, active hepatitis B\u002FC, active infection requiring antibiotics within 2 weeks before enrollment.\n6. Live vaccine administered within 30 days before first dosing.\n7. HIV infection, autoimmune disease requiring systemic therapy within 2 years, long-term systemic immunosuppressants.\n8. Other conditions judged by investigators to interfere with study treatment or assessment.","MALE","18 Years","75 Years",{"count":84,"type":85},29,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","This is an open-label, multicenter, single-arm Phase 2 clinical trial evaluating neoadjuvant pucotenlimab (anti-PD-1 immunotherapy) combined with becotatug vedotin (EGFR-targeted antibody-drug conjugate, ADC) for adults with locally advanced penile squamous cell carcinoma. Eligible patients have high-risk disease defined as T4 primary tumor with any nodal status or any T stage with N2-N3 lymph node metastasis and no distant metastasis.\n\nAll participants receive up to 4 cycles of combination neoadjuvant therapy every 3 weeks. After treatment completion, a multidisciplinary team will assess if consolidative surgery can be performed. Patients who undergo surgery will continue single-agent pucotenlimab adjuvant treatment for 17 additional cycles (approximately 1 year).\n\nThe primary goal is to measure the pathological complete response (pCR) rate. Secondary goals include objective response rate (ORR), progression-free survival (PFS),overall survival (OS) and safty profiles. Blood and tumor tissue samples will be collected to explore biomarkers that may predict treatment response and drug resistance. A total of 29 male patients will be enrolled.",[91,92],"Penile Cancer","Penile Squamous Cell Carcinoma (PSCC)",[94,95,96,97,98],"Penile cancer","Immunotherapy","Antibody-drug conjugate","Pucotenlimab","Becotatug Vedotin","NOT_YET_RECRUITING","2026-08-13",{"date":102,"type":103},"2026-08-17","ACTUAL",{"date":105,"type":85},"2026-08-15",{"date":107,"type":85},"2029-08-15",{"name":5,"class":6},1]