GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
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
Checked against the public recordLast updated Jun 18, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Y-mAbs Therapeutics
- Interventions being studied
- Drug: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi); Drug: GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi); Drug: GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi); Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi); Drug: GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi); Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi); Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 prior to the first planned dosing of the IMP per protocol * Ongoing radiation toxicities from prior RT therapy * Patients with a diagnosis of autoimmune diseases or immunodeficiencies or documented infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (active) * Prior treatment with anti-GD2 antibody
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- HonorHealthScottsdale, Arizona
- City of Hope National Medical CenterDuarte, California
- University of ChicagoChicago, Illinois
- Corewell Health-BAMF HealthGrand Rapids, Michigan
- Memorial Sloan- Kettering Cancer CenterNew York, New York
- Case Western Reserve University, ClevelandCleveland, Ohio
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
- University of Wisconsin-MadisonMadison, Wisconsin
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 18, 2026. Always confirm current availability with the study team.