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

Sichuan University

Status and phase: Enrolling; Early Phase 1

Conditions: Neuroblastoma

Treatments: Drug: IR-101

Study type: Interventional

Funder types: Other

Identifiers

NCT07067346

HX2501

Details and patient eligibility

About

Radiopharmaceutical in Relapsed/Refractory Neuroblastoma

Enrollment: 10 estimated patients

Sex: All

Ages: 12+ months old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Dose Escalation

Experimental group

Description:

Study drug IR-101 Dose Escalation

Treatment:

Drug: IR-101