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

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

Study Purpose

Radiopharmaceutical in Relapsed/Refractory Neuroblastoma

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Months and Over
Gender	All

More Inclusion & Exclusion Criteria

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;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07067346
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sichuan University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rong Tian, MD
Principal Investigator Affiliation	West China Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroblastoma

Arms & Interventions

Arms

Experimental: Dose Escalation

Study drug IR-101 Dose Escalation

Interventions

Drug: - IR-101

IR-101 Dose Escalation

Contact a Trial Team

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