Neuroblastoma
Conditions
Keywords
Radiopharmaceutical
Brief summary
Radiopharmaceutical in Relapsed/Refractory Neuroblastoma
Interventions
DRUGIR-101
IR-101 Dose Escalation
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of dose-limiting toxicities (DLTs) | From administration of IR-101 until 4 weeks after injection | Incidence and severity of dose-limiting toxicities (DLTs) |
| Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0 | From administration of IR-101 until 4 weeks after last dose of injection | Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) | 4 weeks after IR-101 administration | Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) |
| Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry | About 21hours from time of IR-101 administration | Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry |
Countries
China
Contacts
Primary ContactRong Tian, MD
Outcome results
None listed