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

NCT07067346 | Recruiting Early Phase 1

• 1 other identifier: HX2501
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Radiopharmaceutical in Relapsed/Refractory Neuroblastoma

Conditions

Neuroblastoma

Keywords

Radiopharmaceutical

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of dose-limiting toxicities (DLTs)

  Incidence and severity of dose-limiting toxicities (DLTs)

  From administration of IR-101 until 4 weeks after injection

• 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

  From administration of IR-101 until 4 weeks after last dose of injection

Secondary Outcomes (2)

• Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)

  4 weeks after IR-101 administration

• Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry

  About 21hours from time of IR-101 administration

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Study drug IR-101 Dose Escalation

Drug: IR-101

Interventions

IR-101 DRUG

IR-101 Dose Escalation

Dose Escalation

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;
• Adequate organ function and hematologic parameters;

You may not qualify if:

• 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;
• Renal Insufficiency;
• Active Infections;

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (2)

West China Hospital

Chengdu, Sichuang, China

RECRUITING

West China Hospital

Chengdu, China

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Rong Tian, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Tian, MD

CONTACT

18980601586; rongtiannuclear@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 16, 2025
• Study Start: July 18, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)