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NCT05130255Phase 1RECRUITING

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

Study 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

Conditions
SCLCMalignant MelanomaSarcomaHigh Risk Neuroblastoma
Interventions / Drugs
GD2-SADA:177Lu-DOTA Complex
View on ClinicalTrials.gov ↗
Sponsor
YMAB
Y-mAbs Therapeutics
Pediatric Oncology
D40/100
Study Details
Enrollment60 participants
Primary Completion—
Lead SponsorY-mAbs Therapeutics
Data Retrieved2026-04-11 04:32:06.541543+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

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.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 60 participants
Sponsor Catalyst Profile

Y-mAbs Therapeutics (YMAB) is the sponsoring company for this trial. BiotechSign currently grades this company D (40/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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