[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atypical-teratoidrhabdoid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atypical-teratoidrhabdoid-tumors":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100641039","phase-1-phase-i-study-of-becotatug-vedotin-for-safety-and-efficacy-in-egfr-positive-pediatric-relapsedrefractory-or-metastatic-solid-tumors-100641039",false,"NCT07584499","Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed\u002FRefractory or Metastatic Solid Tumors","A Phase I Clinical Study to Explore the Safety and Efficacy of Becotatug Vedotin in Pediatric Patients With EGFR-Positive Relapsed\u002FRefractory or Metastatic Solid Tumors","MRG003","Inclusion Criteria:\n\n* All participants must meet all of the following criteria to be eligible for enrollment:\n\nInformed Consent: The patient (and\u002For legal guardian, as age-appropriate) fully understands the study, voluntarily agrees to participate, and signs a written informed consent form (ICF). A separate biomarker consent form is required for EGFR testing prior to screening.\n\nAge: 2 to 18 years old at the time of consent. Life Expectancy: Estimated overall survival of at least 3 months.\n\nHistologically Confirmed Disease: Pathologically confirmed relapsed\u002Frefractory or metastatic EGFR-positive solid tumor, belonging to one of the following subtypes:\n\nHead and neck squamous cell carcinoma, nasopharyngeal carcinoma, or lymphoepithelial carcinoma that progressed during or after at least one line of platinum-based chemotherapy and PD-1\u002FPD-L1 inhibitor therapy Rhabdomyosarcoma Neuroblastoma Medulloblastoma Wilms tumor Atypical teratoid\u002Frhabdoid tumors (AT\u002FRTs) Diffuse intrinsic pontine gliomas (DIPGs) Other EGFR-positive solid tumor subtypes deemed eligible by the investigator Measurable Disease: At least one measurable tumor lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria (longest diameter ≥10 mm; pathological lymph node short axis ≥15 mm).\n\nPerformance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n\nAdequate Bone Marrow Function:\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL Platelet count ≥75 × 10⁹\u002FL Hemoglobin ≥80 g\u002FL Exception for patients with bone marrow involvement: ANC ≥1.0 × 10⁹\u002FL, platelets ≥50 × 10⁹\u002FL, hemoglobin ≥75 g\u002FL\n\nAdequate Hepatic and Renal Function:\n\nSerum creatinine ≤1.5 × upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN Total bilirubin ≤1.5 × ULN Exception for patients with liver involvement: AST\u002FALT ≤5 × ULN, total bilirubin ≤3 × ULN\n\nExclusion Criteria:\n\n* Participants will be excluded from the study if they meet any of the following criteria:\n\nHypersensitivity: Known hypersensitivity to any component of Becotatug Vedotin (MRG003) or its excipients.\n\nSymptomatic CNS Metastases: Presence of symptomatic central nervous system (CNS) metastases.\n\nPrior Malignancies: History of other primary malignant tumors, except for:\n\nLocally excised basal cell or squamous cell carcinoma of the skin Cervical carcinoma in situ Any prior malignancy that has been in complete remission for ≥3 years without treatment Note: Melanoma (any stage) is explicitly excluded\n\nSignificant Liver Disease: Clinically significant liver disease, including:\n\nPositive hepatitis C virus (HCV) antibody Chronic active hepatitis B (HBV DNA \\>20,000 IU\u002FmL) HIV Infection: Known human immunodeficiency virus (HIV) infection. Severe Ocular Abnormalities: History of severe ophthalmologic conditions, such as severe dry eye syndrome or exposure keratitis.\n\nUncontrolled Systemic Diseases: Severe or uncontrolled medical conditions, including:\n\nInterstitial lung disease or pneumonitis Active autoimmune diseases requiring systemic immunosuppressive therapy\n\nCardiac Disease: Clinically significant cardiac dysfunction or cardiac disease, including:\n\nCongestive heart failure (New York Heart Association Class ≥II) Uncontrolled arrhythmias QTc interval prolongation \\>450 ms (males) or \\>470 ms (females) Recent Antitumor Therapy: Received any systemic antitumor therapy (chemotherapy, biological therapy, immunotherapy, targeted therapy) within 3 weeks prior to the first dose of study drug, and have not recovered to CTCAE v4.03 Grade ≤1 (except alopecia).\n\nRecent Major Surgery: Underwent major surgical procedure within 3 weeks prior to the first dose of study drug.\n\nPlanned Surgery: Planned surgical procedure during the study period, or any surgery deemed necessary by the investigator.\n\nPrior EGFR Therapy Toxicity: History of severe skin toxicity caused by prior EGFR-targeted therapy, or chronic skin disease requiring ongoing oral or intravenous treatment.\n\nOther Significant Risks: Any other concurrent medical condition that, in the investigator's judgment, would increase the risk of toxicity or compromise the patient's ability to complete the study.","ALL","2 Years","18 Years",{"count":21,"type":22},51,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","There is a significant unmet medical need for effective therapies for pediatric relapsed\u002Frefractory solid tumors. EGFR is highly and stably expressed in multiple pediatric solid tumor subtypes, and adult Phase I data of Becotatug Vedotin demonstrated a manageable safety profile and promising antitumor activity in EGFR-positive advanced solid tumors.This is a multicenter, non-randomized, single-arm, open-label Phase I clinical trial sponsored by Sun Yat-sen University Cancer Center (SYSUCC). The trial evaluates the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of Becotatug Vedotin-an EGFR-targeted antibody-drug conjugate (ADC)-in pediatric patients with EGFR-positive relapsed\u002Frefractory or metastatic solid tumors.",[28,29,30,31,32,33,34,35,36,37],"Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent\u002FMetastatic (R\u002FM)","Nasopharyngeal Carcinoma","Lymphoepithelial Carcinoma","Rhabdomyosarcoma","Neuroblastoma","Medulloblastoma","Wilms Tumor","Atypical Teratoid\u002FRhabdoid Tumors","Diffuse Intrinsic Pontine Gliomas","Other EGFR-positive Pediatric Solid Tumors Deemed Eligible by the Investigator","RECRUITING","2026-05-07",{"date":41,"type":42},"2026-05-13","ACTUAL",{"date":44,"type":22},"2026-05-30",{"date":46,"type":22},"2028-05-30",{"name":48,"class":49},"Sun Yat-sen University","OTHER"]