GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Trial Parameters
Brief Summary
Patients with Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex(The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA) to assess safety and tolerability
Eligibility Criteria
Inclusion Criteria: * Signed informed consent from patient, legal guardian(s) and/or adolescents obtained in accordance with local regulations. Pediatric patients must provide assent as required by local regulations. * Age ≥18 years at the time of informed consent, for High Risk Neuroblastoma \& sarcoma age ≥16 years of age at time of informed consent/assent * Measurable disease according to RECIST 1.1 * ECOG performance status 0-1 * Expected survival \>3 months * Platelet counts ≥100,000 cells/mm3 * Hemoglobin ≥9 g/dL * Adequate renal function with serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60mL/min as calculated using the Cockcroft-Gault equation * Patient willing and able to comply with the trial protocol Exclusion Criteria: * Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol * Patients receiving any other investigational therapy for their cancer within 3 weeks p