[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632845":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":27,"enrollmentInfo":69,"targetDuration":27,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":82,"whyStopped":27,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"West China Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Becotatug Vedotin + Pucotenlimab Neoadjuvant Arm","EXPERIMENTAL","This single-arm, phase II intervention arm evaluates neoadjuvant therapy with Becotatug Vedotin (an EGFR-targeting antibody-drug conjugate) combined with Pucotenlimab (a PD-1 inhibitor) in patients with EGFR-expressing locally advanced penile squamous cell carcinoma (PSCC) who have penile preservation difficulty or regional lymph node metastasis.\n\nAll eligible participants receive the same standardized regimen: intravenous infusion of Becotatug Vedotin at 2.0 mg\u002Fkg and Pucotenlimab at 200 mg, administered once every 3 weeks for 4 to 6 cycles. Following neoadjuvant treatment, tumor resectability is assessed by a multidisciplinary team (MDT). Patients with resectable disease undergo radical surgery (penile-sparing resection or total\u002Fpartial penectomy plus inguinal\u002Fpelvic lymph node dissection as indicated). Those achieving R0 resection (complete resection with negative margins) receive adjuvant Pucotenlimab for 1 year to consolidate antitumor immunity.",[13,14],"Drug: Becotatug Vedotin","Drug: Pucotenlimab",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Becotatug Vedotin","Becotatug vedotin is an EGFR-targeted antibody-drug conjugate (ADC) composed of a high-affinity anti-EGFR monoclonal antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable valine-citrulline linker. In this phase II neoadjuvant trial, it is administered intravenously at a dose of 2.0 mg\u002Fkg once every 3 weeks for 4-6 cycles, in combination with Pucotenlimab, for patients with EGFR-expressing locally advanced penile squamous cell carcinoma.",[9],[22],"MRG003",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Pucotenlimab","Pucotenlimab is a humanized, high-affinity anti-PD-1 monoclonal antibody that blocks PD-1\u002FPD-L1\u002FPD-L2 binding to reactivate antitumor immunity. In this trial, it is administered intravenously at 200 mg once every 3 weeks: 4-6 cycles as neoadjuvant therapy with Becotatug vedotin, followed by 1 year of adjuvant therapy for patients achieving R0 resection, for EGFR-expressing locally advanced penile squamous cell carcinoma.",[9],null,[29],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Hong-Shuai Li, Dr","CONTACT","+86-18384262516","lihongshuai456@163.com",[35],{"facility":36,"status":27,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"West China Hospital of Sichuan University","Chengdu","Sichuan","610041","China","CN",{"type":43,"coordinates":44},"Point",[45,46],104.06667,30.66667,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":32,"phoneExt":27,"email":33},"Hongshuai Li, Dr",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Jiyan Liu","Deputy Director of the Department of Biotherapy, West China Hospital, Sichuan University",[56],{"name":57,"class":58},"Lepu Medical Technology (Beijing) Co., Ltd.","INDUSTRY","100632845","phase-2-egfr-adc-becotatug-vedotin-combined-with-pd-1-inhibitor-pucotenlimab-in-neoadjuvant-treatment-of-advanced-penile-cancer-100632845",false,"NCT07518979","EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer","Neoadjuvant Therapy With EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) for Penile Squamous Cell Carcinoma With Penile Preservation Difficulty or Regional Lymph Node Metastasis: A Single-Arm, Phase II Clinical Trial","MH-Penile-002","1. Inclusion Criteria （1）Histologically\u002Fcytologically confirmed penile squamous cell carcinoma (PSCC); （2）EGFR expression (IHC 1+, 2+, or 3+) confirmed by local pathology department; （3）No prior systemic therapy, or recurrence ≥6 months after adjuvant therapy for radical resection; （4）Male, aged ≥18 years; （5）Cytologically positive or clinically palpable inguinal lymphadenopathy, fixed mass, radiologically diagnosed pelvic lymph node metastasis, or penile preservation difficulty (unable to perform surgery with negative margin and functional penile stump preservation); （6）At least one measurable lesion per RECIST 1.1; （7）Adequate organ function:\n\n   * Left ventricular ejection fraction (LVEF) ≥50%;\n   * Hemoglobin (HGB) ≥90 g\u002FL, white blood cell (WBC) ≥3.0×10⁹\u002FL, absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet (PLT) ≥80×10⁹\u002FL;\n   * Total bilirubin (TBIL) ≤1.5×ULN, AST\u002FALT ≤2.5×ULN (≤5×ULN for liver metastasis), serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL\u002Fmin; （8）Voluntarily participate, understand the study, and sign informed consent form.\n2. Exclusion Criteria （1）Prior systemic therapy (except recurrence ≥6 months after adjuvant chemotherapy for radical resection); （2）Severe concurrent diseases or poor physical condition unsuitable for treatment\u002Fsurgery (e.g., severely ulcerated\u002Finfected inguinal lymph nodes with high risk of poor wound healing); （3）Uncontrolled comorbidities: uncontrolled infection, active tuberculosis, uncontrolled diabetes, cardiovascular diseases (NYHA class III\u002FIV heart failure, ≥grade 2 heart block, myocardial infarction within 12 months, unstable arrhythmia\u002Fangina, cerebral infarction within 6 months), interstitial lung disease, deep vein thrombosis\u002Fpulmonary embolism within 12 months, decompensated cirrhosis; （4）Active autoimmune diseases requiring systemic treatment within 2 years (except physiological replacement therapy); （5）Positive serological tests: HIV positive; HBsAg positive with HBV DNA ≥2000 copies\u002FmL; HCV antibody positive with positive HCV RNA; （6）Major surgery within 4 weeks prior to enrollment, prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation; （7）Vaccination with anti-tumor vaccine within 4 weeks prior to enrollment or planned during the study; （8）Other conditions deemed unsuitable by the investigator.","MALE","18 Years",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","This clinical study is a Phase II research trial focused on a new preoperative treatment for men with advanced penile squamous cell carcinoma (a type of penile cancer). The cancer may be hard to treat with penile-sparing surgery, or it may have spread to nearby lymph nodes (like groin lymph nodes).\n\nWe are testing a combination of two medicines: Becotatug vedotin (a targeted therapy that finds and kills cancer cells with high levels of a protein called EGFR) and Pucotenlimab (an immunotherapy that helps your body's immune system fight cancer). The goal is to see if this combination can shrink the tumor, make surgery more likely to remove all cancer cells, and improve treatment outcomes-while keeping side effects manageable.\n\nWho can join?\n\nTo be eligible, you must:\n\nBe a man 18 years or older with confirmed penile squamous cell carcinoma; Have cancer that is hard to treat with penile-sparing surgery or has spread to regional lymph nodes; Have cancer cells that test positive for EGFR (a protein most penile cancers make); Have not received prior systemic cancer treatment (or had recurrence more than 6 months after adjuvant therapy for radical resection); Have adequate organ function (e.g., healthy heart, liver, and kidney function) to tolerate treatment; Understand the study and voluntarily agree to participate by signing an informed consent form.\n\nWhat will happen during the study? Screening (up to 28 days): You will have tests to confirm eligibility, including imaging scans, blood work, and EGFR testing on your tumor sample.\n\nPreoperative treatment (4-6 cycles): You will receive intravenous infusions of Becotatug vedotin (2.0 mg\u002Fkg) and Pucotenlimab (200 mg) every 3 weeks. Every 6 weeks, you will have imaging scans to check if the tumor is shrinking.\n\nSurgery: If the tumor responds to treatment (assessed by a team of doctors), you will undergo radical surgery to remove the cancer. If surgery is successful, you may continue Pucotenlimab as adjuvant therapy for 1 year.\n\nFollow-up: After treatment, you will be checked every 3 months for 2 years to monitor for cancer recurrence and long-term side effects.\n\nWhat are the study goals? Primary goal: To find out how many patients can have successful surgery to remove all visible cancer (R0 resection) after the combination treatment.\n\nSecondary goals: To measure how much the tumor shrinks (objective response rate), if the cancer stage improves (downstaging rate), if surgery removes all cancer cells (pathological complete response rate), how long patients stay cancer-free (disease-free survival), and how safe the treatment is.\n\nWhat are the potential risks? As with any cancer treatment, this combination may cause side effects. Common expected side effects include skin reactions (e.g., rash), digestive issues, changes in blood cell counts, liver function changes, and immune-related reactions (e.g., thyroid problems, lung inflammation). These side effects will be closely monitored by the study team, and treatments to manage them will be provided.\n\nThis study is being conducted at West China Hospital, Sichuan University. It is a single-arm trial (all participants receive the same combination treatment) and will enroll about 60 patients. The study is expected to run from April 2026 to April 2028.",[77],"Penile Cancer",[79,80,81],"penile cancer","ADC","PD-1","NOT_YET_RECRUITING","2026-06-30",{"date":85,"type":86},"2026-07-01","ACTUAL",{"date":88,"type":71},"2026-07-30",{"date":90,"type":71},"2031-05-01",{"name":53,"class":6},1]