Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma
ConditionNeuroblastoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorSichuan University
About this trial
Radiopharmaceutical in Relapsed/Refractory Neuroblastoma
Eligibility criteria
Qualifiers
Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria (INRC);
All soft-tissue lesions detected on CT/MRI must be MIBG-avid;
Age ≥12 months;
Lansky performance status ≥50%;
Disqualifiers
Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic therapies；
Treatment with [¹³¹I]MIBG or Lu-177 targeted radionuclide therapy <3 months of last administration;
Autologous transplant <12 weeks, or Allogeneic transplant <4 months (patients >4 months post-transplant must be free of active GVHD);
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;
Trial design
Treatments tested in this trial
- IR-101
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov