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

Study Overview

• Status: Recruiting
• Conditions: Neuroblastoma (NB)
• Intervention / Treatment: Drug: [211At]MABG

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Rong TIAN, MD; Phone Number: +86 189 8060 1586; Email: rongtiannuclear@126.com
• Study Contact Backup: Name: Xiaoao WU, PHD; Phone Number: +86 189 8060 2715; Email: allenfire511@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 000000
      • Recruiting
      • West China Hospital
      • Contact: Rong TIAN; Phone Number: +86 189 8060 1586; Email: rongtiannuclear@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [211At]MABG; Fractionated Dose	Drug: [211At]MABG; Fractionated Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of dose-limiting toxicities (DLTs)	Incidence and severity of dose-limiting toxicities (DLTs)	From administration of [211At]MABG until 4 weeks after injection
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	From administration of [211At]MABG until 4 weeks after last dose of injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	About 21hours from time of [211At]MABG administration]
Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)	Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)	8 weeks after [211At]MABG administration, Participants without disease progression (PD) will be evaluated every 8 weeks for the first 24 weeks, then every 12 weeks until PD, new cancer therapy, death, or study termination

Collaborators and Investigators

• Sponsor: Sichuan University
• Investigators: Principal Investigator: Rong TIAN, MD, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 12, 2026
• First Submitted That Met QC Criteria: August 12, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Radiopharmaceutical
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neuroblastoma
• Other Study ID Numbers: HX2602

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No