drugset / Trial / NCT05130255

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

NCT05130255 ↗

Phase 1 Terminated 23 enrolled Y-mAbs Therapeutics
Non-randomizedSequentialSingle-blindTreatment

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

Timeline

Start
2022-11-17
Primary completion
2026-03-11
Completion
2026-03-11

Outcome

Outcome not reported

Stopped: “Decision by Sponsor”

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-DOTA Unknown 1110 mbq Intravenous
Subject 177Lu-DOTA Unknown 3700 mbq Intravenous
Subject 177Lu-DOTA Unknown 7400 mbq Intravenous
Subject GD2-SADA Unknown 0.3 mg/kg Intravenous
Subject GD2-SADA Unknown 1 mg/kg Intravenous
Subject GD2-SADA Unknown 3 mg/kg Intravenous