Safety, Tolerability, and Preliminary Efficacy of [211At]MABG in Patients With Relapsed or Refractory Neuroblastoma

An Exploratory Proof-of-Concept (POC) Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Fractionated Dosing of [211At]MABG in Patients With Relapsed or Refractory Neuroblastoma (Including a Run-in Phase)

Fractionated dosing of [211At]MABG Radiotherapy in Relapsed/Refractory Neuroblastoma

Fractionated dosing of [211At]MABG Radiotherapy in Relapsed/Refractory Neuroblastoma

Inclusion Criteria:

1. Patients diagnosed with MIBG avid lesions, high-risk neuroblastoma per the Revised International Neuroblastoma Response Criteria (Revised INRC), with refractory, relapsed, or progressive disease.
2. All measurable soft tissue lesions must be MIBG-avid.
3. Age ≥ 1 year at enrollment.
4. Lansky performance status ≥ 50%.
5. Adequate organ function and hematologic parameters.

Exclusion Criteria:

1. 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.
2. Treatment with [¹³¹I]MIBG or Lu177 targeted radionuclide therapy less than 3 months of last administration.
3. Autologous stem cell transplant <12 weeks, or Allogeneic stem cell transplant <4 months (patients >4 months post-transplant must be free of active GVHD).
4. 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.
5. Renal Insufficiency.
6. Active Infections.