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RecruitingNCT07767630Updated Aug 21, 2026

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

An Early Phase 1 interventional study of [211At]MABG in Neuroblastoma (NB), sponsored by Sichuan University. Recruiting at 1 site in China. Open to participants aged 1 Year to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Sichuan University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
1 Year to 100 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Neuroblastoma (NB)

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Keywords

  • Radiopharmaceutical
03

In context

Neuroblastoma

675 studies on the registry are indexed under Neuroblastoma; 127 are open to participants now.

This study's planned enrollment of 10 is below the median of 32 across 507 interventional studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

Sichuan University is the lead sponsor of 107 studies on the registry; 66 are open to participants now.

Browse Sichuan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients diagnosed with MIBG avid lesions, high-risk neuroblastoma per the Revised International Neuroblastoma Response Criteria (Revised INRC), with , 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

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. stem cell transplant \<12 weeks, or Allogeneic stem cell transplant \<4 months (patients >4 months post-transplant must be free of active ).
  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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    [211At]MABG

    Fractionated Dose

    Drug: [211At]MABG

Interventions

  • Drug[211At]MABG

    Fractionated Dose

06

What researchers measure

Primary outcomes

  1. Incidence and severity of dose-limiting toxicities (DLTs)

    Incidence and severity of dose-limiting toxicities (DLTs)

    Time frame: From administration of [211At]MABG until 4 weeks after injection

  2. 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

    Time frame: From administration of [211At]MABG until 4 weeks after last dose of injection

Secondary outcomes

  1. Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)

    Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)

    Time frame: 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

  2. 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

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.

Of 73 non-industry phase 1 interventional studies under Neuroblastoma, half reached primary completion within 89 months of starting (the median), counting those still running; a quarter within 65 and three quarters within 117. This study's planned 11 months is below that.

Counting every sponsor, half of 86 studies reached it within 83 months; a quarter within 60 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 17, 2026
StartActual
Jul 21, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07767630
Lead sponsor
Sichuan University
Responsible party
Rong Tian (Professor, Sichuan University) — Principal investigator
First posted
Aug 17, 2026
Start date
Jul 21, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

Rong TIAN, MD
Contact
rongtiannuclear@126.com
+86 189 8060 1586
Xiaoao WU, PHD
Contact
allenfire511@163.com
+86 189 8060 2715
Rong TIAN, MD
principal investigator · West China Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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