eligibility_summary
Inclusion: Age 2-21, histologic Ewing sarcoma (bone/soft tissue), GD2+ by IHC with FFPE sample, progression/recurrence after >=1 prior line, life expectancy >=12 wks, recovered, washouts: systemic >=3 wks, surgery >=2 wks, RT >=4 wks, consent and contraception. Exclusion: not eligible for IT, prior anti-GD2, hypersensitivity/interacting drugs, persistent toxicity, QTc>480, CHF/LVEF<50%, pulmonary dysfunction/SpO2<94%, steroids >10 mg, other cancer, pregnancy/breastfeeding, other serious risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 2, randomized (2:1) trial in GD2-positive refractory Ewing sarcoma comparing standard IT (irinotecan+temozolomide) vs IT plus naxitamab and GM‑CSF. Naxitamab (Danyelza) is a humanized anti‑GD2 IgG1 monoclonal antibody, it binds the disialoganglioside GD2 on tumor cells to trigger antibody‑dependent cellular cytotoxicity (ADCC) and complement‑dependent cytotoxicity, engaging NK cells and myeloid effectors. GM‑CSF (cytokine) is added to expand/activate granulocyte–macrophage lineage cells to enhance ADCC. Irinotecan is a topoisomerase I inhibitor (camptothecin) causing replication‑associated DNA breaks. Temozolomide is an oral alkylating agent that methylates DNA (notably O6‑guanine) leading to tumor cell death. Targets/pathways: GD2 on Ewing sarcoma cells, FcγR‑mediated ADCC/complement, topoisomerase I–dependent DNA replication, DNA damage/repair pathways. Enrollment requires GD2 expression by IHC.