NCT05130255TerminatedPhase 1
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 11 Nov 2021
- Start date
- 17 Nov 2022
- Primary completion date
- 11 Mar 2026
- Lead sponsor
- Y-mAbs Therapeutics
- Diseases
- Neuroblastoma, Melanoma, Lung cancer, Childhood cancers, Sarcoma
- NCT number
- NCT05130255
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Prior treatment with anti-GD2 antibody
Other illness
- Patients with a diagnosis of autoimmune diseases or immunodeficiencies or documented infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (active)
Who the study is looking for
- 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
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Case Western Reserve University, Cleveland Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Corewell Health-BAMF Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| HonorHealth Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.