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

NCT ID: NCT07067346

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-18
• Study Completion Date: 2026-06-30

Brief Summary

Radiopharmaceutical in Relapsed/Refractory Neuroblastoma

Conditions

Neuroblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation

Study drug IR-101 Dose Escalation

Group Type: EXPERIMENTAL

IR-101

Intervention Type: DRUG

IR-101 Dose Escalation

Interventions

IR-101

IR-101 Dose Escalation

Intervention Type: DRUG

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;

• Minimum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Rong Tian

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rong Tian, MD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital

Chengdu, Sichuang, China

Site Status: RECRUITING

West China Hospital

Chengdu, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Rong Tian, MD

Role: CONTACT

rongtiannuclear@126.com

18980601586

Facility Contacts

Xiaoai Wu, Phd

Role: primary

Xiaoai Wu

Role: primary

Other Identifiers

HX2501

Identifier Type: -

Identifier Source: org_study_id