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NCT05558280

Qarziba for Patients in Relapsed/Refractory High-grade Osteosarcoma

Suspended Phase 2 Last updated 18 November 2023
What this trial tests

Phase 2 trial testing Dinutuximab beta in Osteosarcoma in Children in 22 participants. Suspended.

Timeline
30 November 2023
Primary endpoint
15 December 2025
15 December 2026

Quick facts

Lead sponsorProf. Franca Fagioli
PhasePhase 2
StatusSuspended
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment22
Start date30 November 2023
Primary completion15 December 2025
Estimated completion15 December 2026
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Prof. Franca Fagioli

Who can join

Adults 1 to 25, any sex, with Osteosarcoma in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Limited progress has been made in identifying novel targets that may be therapeutic for Osteosarcoma(OS) and there remains an urgent need for the development of new agents that are effective in improving survival. From this perspective, repurposing already proven targets in other tumors may offer new opportunities for OS in children and young adults. Anecdotal evidence of anti-GD2 therapy exists in OS from prior Phase 1 trials that included patients with OS.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Aberrant Glycosylation as Immune Therapeutic Targets for Solid Tumors.
    Matsumoto Y, Ju T. · · 2023 · cited 31× · PMID 37509200 · DOI 10.3390/cancers15143536
  2. Global Impact of Monoclonal Antibodies (mAbs) in Children: A Focus on Anti-GD2.
    Larrosa C, Mora J, Mora J, Cheung NK. · · 2023 · cited 13× · PMID 37509390 · DOI 10.3390/cancers15143729
  3. Targeted therapies in pediatric oncology: A start.
    Shah N. · · 2026 · PMID 41994561 · DOI 10.1016/j.omton.2026.201146

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Other trials of Dinutuximab beta

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing