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
Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.
This trial was terminated before completion. Termination can indicate safety signals, futility findings, or business/regulatory decisions by the sponsor.
Y-mAbs Therapeutics (YMAB) is the sponsoring company for this trial. BiotechSign currently grades this company C (63/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.