OncoMatch/Clinical Trials/NCT05130255

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

Is NCT05130255 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies GD2-SADA:177Lu-DOTA Complex for sclc.

Phase 1RecruitingY-mAbs TherapeuticsNCT05130255Data as of May 2026

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

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Extracted eligibility criteria

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)

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 →

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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