Actively Recruiting

Early Phase 1
Age: 12Months +
All Genders
NCT07067346

Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma

Led by Sichuan University · Updated on 2025-07-29

10

Participants Needed

2

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Radiopharmaceutical in Relapsed/Refractory Neuroblastoma

CONDITIONS

Official Title

Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma

Who Can Participate

Age: 12Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions per Revised International Neuroblastoma Response Criteria (INRC)
  • All soft-tissue lesions on CT or MRI must be MIBG-avid
  • Age 12 months or older
  • Lansky performance status of 50% or higher
  • Adequate organ function and hematologic parameters
Not Eligible

You will not qualify if you...

  • Received antibody-based immunotherapy within 5 half-lives or 30 days, or not recovered from prior biologic therapy adverse reactions
  • Treated with I-131 MIBG or Lu-177 targeted radionuclide therapy within 3 months prior
  • Autologous transplant less than 12 weeks ago or allogeneic transplant less than 4 months ago; must be free of active GVHD if more than 4 months post-transplant
  • Radiotherapy within 2 weeks prior to first dose, except for patients with MIBG uptake after radiotherapy completion; extensive-field radiotherapy within 12 weeks prior
  • Presence of renal insufficiency
  • Active infections

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

West China Hospital

Chengdu, Sichuang, China

Actively Recruiting

2

West China Hospital

Chengdu, China

Actively Recruiting

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Research Team

R

Rong Tian, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma | DecenTrialz