[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641039":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":48,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Becotatug Vedotin (MRG003) Phase I Dose-Escalation & Expansion in EGFR-Positive Pediatric R\u002FM Solid","EXPERIMENTAL","This is a single-arm, open-label study where all enrolled participants receive Becotatug Vedotin (MRG003), a novel EGFR-targeted antibody-drug conjugate (ADC), as monotherapy.\n\nIntervention Details Study Drug: Becotatug Vedotin (MRG003) for Injection Route of Administration: Intravenous (IV) infusion over 30 minutes to 3 hours Dosing Schedule: Every 3 weeks (Q3W) on Day 1 of each 21-day cycle Maximum Treatment Duration: Up to 8 cycles (24 weeks)\n\nDose Levels:\n\nIa Dose-Escalation Phase: 4 planned dose levels (1.0, 1.5, 2.0, 2.3 mg\u002Fkg) Starting dose: 1.0 mg\u002Fkg (modified accelerated titration design, 1 patient per cohort) Subsequent doses: Standard 3+3 design Ib Dose-Expansion Phase: All patients receive the determined Recommended Phase II Dose (RP2D)",[13],"Drug: Becotatug Vedotin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Becotatug Vedotin","Study Drug: Becotatug Vedotin (MRG003) for Injection (lyophilized powder, 20 mg\u002Fvial) Route: Intravenous (IV) infusion over 30 minutes to 3 hours Schedule: Every 3 weeks (Q3W) on Day 1 of each 21-day cycle Maximum Treatment Duration: Up to 8 cycles (24 weeks); patients with confirmed clinical benefit (objective response or stable disease) may continue treatment beyond 8 cycles until disease progression, unacceptable toxicity, withdrawal of consent, or study termination",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yizhuo Zhang","CONTACT","020-87342460","zhangyzh@sysucc.org.cn",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":37,"coordinates":38},"Point",[39,40],113.25,23.11667,{"lat":40,"lon":39},[43,46],{"name":44,"role":24,"phone":25,"phoneExt":20,"email":45},"Yi Que","queyi@sysucc.org.cn",{"name":23,"role":47,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":23,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Professor, director of department of pediatric oncology","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":62,"type":63},51,"ESTIMATED","INTERVENTIONAL",[66],"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.",[69,70,71,72,73,74,75,76,77,78],"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","2026-05-07",{"date":81,"type":82},"2026-05-13","ACTUAL",{"date":84,"type":63},"2026-05-30",{"date":86,"type":63},"2028-05-30",{"name":5,"class":6},1]