OncoMatch/Clinical Trials/NCT05130255
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Is NCT05130255 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies GD2-SADA:177Lu-DOTA Complex for sclc.
Treatment: GD2-SADA:177Lu-DOTA Complex — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Cancer type
Small Cell Lung Cancer
Melanoma
Sarcoma
Neuroblastoma
Biomarker criteria
Required: GD2 expression (known to express GD2)
solid tumors known to express GD2
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic chemotherapy
Exception: within 3 weeks prior to first planned dosing
Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol
Cannot have received: radiotherapy
Exception: within 3 weeks prior to first planned dosing
Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol
Cannot have received: immunotherapy
Exception: within 3 weeks prior to first planned dosing
Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol
Cannot have received: major surgery
Exception: within 3 weeks prior to first planned dosing
Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol
Cannot have received: investigational therapy
Exception: within 3 weeks prior to first planned dosing
Patients receiving any other investigational therapy for their cancer within 3 weeks prior to the first planned dosing of the IMP per protocol
Cannot have received: anti-GD2 antibody
Prior treatment with anti-GD2 antibody
Lab requirements
Blood counts
platelet counts ≥100,000 cells/mm3; hemoglobin ≥9 g/dl
Kidney function
serum creatinine ≤1.5 mg/dl or creatinine clearance ≥60ml/min as calculated using the cockcroft-gault equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- HonorHealth · Scottsdale, Arizona
- City of Hope National Medical Center · Duarte, California
- University of Chicago · Chicago, Illinois
- Corewell Health-BAMF Health · Grand Rapids, Michigan
- Memorial Sloan- Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05130255 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic chemotherapy, radiotherapy, immunotherapy disqualifies patients from enrollment.
Does this trial require GD2?
Yes, GD2 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages