drugset / Trial / NCT06839703

International Phase I Trial of Dinutuximab Beta With VDC/IE in GD2-Positive Ewing Sarkoma

NCT06839703

Phase 1 Not yet recruiting 18 enrolled Prof. Dr. Dirk Reinhardt
NaSingle-groupOpen-labelTreatment

Summary

The goal of the study is to investigate the feasibility, toxicity, and biological activity of the treatment with dinutuximab beta in combination with standard chemotherapy in EWS to give high-risk patients with a GD2 positiv pumor a benefit in treatment. Within the study is tested with three different dosages in a 3+3 design with three pre-defined dose levels.

Timeline

Start
2025-03-01
Primary completion
2027-03-01
Completion
2027-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinutuximab Monoclonal antibody 100 mg/m2

Indications