drugset / Trial / NCT05080790

Treatment With Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients With Leiomyosarcoma

NCT05080790

NaSingle-groupOpen-labelTreatment

Summary

Dinutuximab beta was designed to bind to neuroblastoma cells and other cancer cells that express the GD2 antigen, such as STS/LMS cells, and it is believed that this binding "labels" the cells an makes them a better target. In addition, γδ T cells can safely be expanded in-vivo using intravenous zoledronic acid and subcutaneous interleukin-2 (IL-2) in patients with different types of solid tumors \[Dieli et al., 2007; Pressey et al., 2016\]. It is supposed that combination treatment using dinutuximab beta, zoledronic acid and IL-2 is more effective than their use in isolation. The already-established safety profiles of these agents make testing of the combination in GD2 positive cancers such as GD2 expressing LMS both rational and feasible \[Fisher et al., 2015\].

Timeline

Start
2021-11-15
Primary completion
2025-01-20
Completion
2025-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinutuximab Monoclonal antibody 20 mg/m2
Subject Zoledronic acid Other / unclassified 4 mg Intravenous
Subject aldesleukin Protein / enzyme biologic 5.4e+06 unknown Subcutaneous

Indications