TerminatedPhase 1NCT05130255

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

StatusTerminated
PhasePhase 1
U.S. locations8
SponsorY-mAbs Therapeutics
01
Study overview

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)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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