Recruiting NCT07067346

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

Early Phase I Interventional Neuroblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: IR-101.
Who it may be relevant to: Registry conditions: Neuroblastoma. Basic parameters: from 12 months · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Study to Evaluate Safety and Efficacy of Radiopharmaceutical IR-101 in Patients With Relapsed or Refractory Neuroblastoma

Radiopharmaceutical in Relapsed/Refractory Neuroblastoma

Incidence and severity of dose-limiting toxicities (DLTs) [Time frame: From administration of IR-101 until 4 weeks after injection]
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0 [Time frame: From administration of IR-101 until 4 weeks after last dose of injection]

Secondary outcome measures (2)

Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) [Time frame: 4 weeks after IR-101 administration]
Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry [Time frame: About 21hours from time of IR-101 administration]

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%;
Adequate organ function and hematologic parameters;

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;
Renal Insufficiency;
Active Infections;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 2 centers

NCT: NCT07067346 · HX2501