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

Stopped early · Phase 1

Conditions studied: SCLC, Malignant Melanoma, Sarcoma, High Risk Neuroblastoma

In brief

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

Key facts

Study ID

NCT05130255

Run by

Y-mAbs Therapeutics

People needed

23

Starts

2022-11-17

Expected to finish

2026-03-11

Last updated by the study team

2026-06-18

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• HonorHealth — Scottsdale, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• University of Chicago — Chicago, Illinois, United States
• Corewell Health-BAMF Health — Grand Rapids, Michigan, United States
• Memorial Sloan- Kettering Cancer Center — New York, New York, United States
• Case Western Reserve University, Cleveland — Cleveland, Ohio, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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