IR-101 for relapsed or refractory neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early Phase 1 interventional trial gives participants IR-101, a radiopharmaceutical targeted to MIBG-avid neuroblastoma lesions, to characterize safety and preliminary efficacy. Eligible patients must have relapsed or refractory high-risk neuroblastoma with all soft-tissue lesions showing MIBG uptake, be at least 12 months old, have Lansky performance ≥50%, and meet organ function and blood-count requirements. Key exclusions include recent antibody immunotherapy, recent [131I]MIBG or Lu-177 radionuclide therapy, recent autologous or allogeneic transplant within protocol windows, active GVHD, or very recent radiotherapy. The trial is conducted at West China Hospital in Chengdu and will follow participants through treatment and post-treatment safety and response assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria (INRC);
2. All soft-tissue lesions detected on CT/MRI must be MIBG-avid;
3. Age ≥12 months;
4. Lansky performance status ≥50%;
5. Adequate organ function and hematologic parameters;

Exclusion Criteria:

1. Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic therapies；
2. Treatment with \[¹³¹I\]MIBG or Lu-177 targeted radionuclide therapy \<3 months of last administration;
3. Autologous transplant \<12 weeks, or Allogeneic transplant \<4 months (patients \>4 months post-transplant must be free of active GVHD);
4. Radiotherapy within 2 weeks prior to first dose of study drug (However, if the subjects undergone radiotherapy for the sole lesion have MIBG uptake after 2 weeks of radiotherapy completion, they will be eligible); or Extensive-field radiotherapy (e.g., Cranio-spinal cord, whole lung, whole abdomen, or \>50% bone marrow) within 12 weeks prior to first dose of study drug;
5. Renal Insufficiency;
6. Active Infections;

Where it's running

• West China Hospital
  Chengdu, Sichuang, China Recruiting
• West China Hospital
  Chengdu, China Recruiting

Study contacts

• Principal investigator: Rong Tian, MD — West China Hospital
• Study coordinator: Rong Tian, MD
• Email: rongtiannuclear@126.com
• Phone: 18980601586

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.