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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
IR-101
DrugIR-101 Dose Escalation
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of dose-limiting toxicities (DLTs)
Incidence and severity of dose-limiting toxicities (DLTs)
Time frame
From administration of IR-101 until 4 weeks after injection2
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
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 injectionSecondary outcomes
1
Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Time frame
4 weeks after IR-101 administration2
Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
Time frame
About 21hours from time of IR-101 administrationSponsors and contacts
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Source ClinicalTrials.gov