NCT07067346 Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma
| NCT ID | NCT07067346 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Sichuan University |
| Condition | Neuroblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-07-18 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-07-18 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Radiopharmaceutical in Relapsed/Refractory Neuroblastoma
Eligibility 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;
Contact & Investigator
Rong Tian, MD
PRINCIPAL INVESTIGATOR
West China Hospital
Frequently Asked Questions
Who can join the NCT07067346 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07067346 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07067346 currently recruiting?
Yes, NCT07067346 is actively recruiting participants. Contact the research team at rongtiannuclear@126.com for enrollment information.
Where is the NCT07067346 trial being conducted?
This trial is being conducted at Chengdu, China, Chengdu, China.
Who is sponsoring the NCT07067346 clinical trial?
NCT07067346 is sponsored by Sichuan University. The principal investigator is Rong Tian, MD at West China Hospital. The trial plans to enroll 10 participants.