NCT05968768 To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)
| NCT ID | NCT05968768 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Anna Raciborska |
| Condition | Ewing Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-10-24 |
| Primary Completion | 2027-05-01 |
Trial Parameters
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Brief Summary
Prospective, interventional, open, randomized, national, multicenter, non-commercial trial
Eligibility Criteria
Inclusion Criteria: 1. Histologically proven Ewing sarcoma of the bone or soft tissues. 2. Subject's archival tumour sample (formalin-fixed, paraffin-embedded; FFPE) available for evaluation of GD2 expression. 3. Documented disease progression (during or after completion of at least one line treatment) or any subsequent recurrence. 4. GD2 positive tumor assessed by IHC. 5. Age ≥ 2 years and ≤ 21 years. 6. Life expectancy of at least 12 weeks from the time informed consent was signed. 7. Previous systemic anticancer treatment completed ≥ 3 weeks, major surgery ≥ 2 weeks, and radiation therapy ≥ 4 weeks prior to study enrollment. 8. Recovered from adverse effects of prior surgery, radiotherapy, or Clinical trial protocol BUTTERFLY version 1.0 of 30.09.2022 r.anti-neoplastic therapy at the discretion of the investigator. 9. Signing of informed consent for trial participation (including for naxitamab treatment) according with current legal regulations. 10. Consent to the use of effective c