GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi) and GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi)

Plus 5 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 18, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Y-mAbs Therapeutics

Study sponsor

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)

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How this study is categorized

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

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

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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