Fractionated dosing of \[211At\]MABG Radiotherapy in Relapsed/Refractory Neuroblastoma
Patients diagnosed with MIBG avid lesions, high-risk neuroblastoma per the Revised International Neuroblastoma Response Criteria (Revised INRC), with refractory, relapsed, or progressive disease.
All measurable soft tissue lesions must be MIBG-avid.
Age ≥ 1 year at enrollment.
Lansky performance status ≥ 50%.
Antibody-based immunotherapy within fewer than 5 half-lives or 30 days (whichever is shorter), or who have not yet recovered from adverse effects of any biologic therapy.
Treatment with [¹³¹I]MIBG or Lu177 targeted radionuclide therapy less than 3 months of last administration.
Autologous stem cell transplant <12 weeks, or Allogeneic stem cell transplant <4 months (patients >4 months post-transplant must be free of active GVHD).
Radiotherapy within 2 weeks prior to the first study dose (However, patients with a single-site irradiation that remains MIBG avid may be enrolled.) or extensive-field radiotherapy (e.g., craniospinal, whole abdomen, whole lung, or >50% of bone marrow area) within 12 weeks prior to the first study dose.
Single group
[211At]MABG
DrugFractionated Dose
Incidence and severity of dose-limiting toxicities (DLTs)
Incidence and severity of dose-limiting toxicities (DLTs)
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
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