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

NCT07767630 | Recruiting Early Phase 1

• 1 other identifier: HX2602
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuroblastoma (NB)

Keywords

Radiopharmaceutical

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

• Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry

  About 21hours from time of [211At]MABG administration]

Study Arms (1)

[211At]MABG

EXPERIMENTAL

Fractionated Dose

Drug: [211At]MABG

Interventions

[211At]MABG DRUG

Fractionated Dose

[211At]MABG

Eligibility Criteria

• Age: 1 Year - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.
• Adequate organ function and hematologic parameters.

You may not qualify if:

• 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.
• Renal Insufficiency.
• Active Infections.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 000000, China

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Rong TIAN, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong TIAN, MD

CONTACT

+86 189 8060 1586; rongtiannuclear@126.com

Xiaoao WU, PHD

CONTACT

+86 189 8060 2715; allenfire511@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: July 21, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

CN (1)