Recruiting EARLY_PHASE1 Neuroblastoma

Tests treatment safety and results for Neuroblastoma

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

ClinicalTrials.gov ID: NCT07067346

What this study is testing

What is IR-101?

IR-101 is an investigational medicine, being studied as a potential treatment for neuroblastoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Radiopharmaceutical in Relapsed/Refractory Neuroblastoma
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 and older

You may be able to join if

  • Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria...
  • 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 likely can't join if

  • Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic...
  • Treatment with [¹³¹I]MIBG or Lu-177 targeted radionuclide therapy \<3 months of last administration;
  • Autologous transplant \ 4 months post-transplant must be free of active GVHD);
  • Radiotherapy within 2 weeks prior to first dose of study drug (However, if the people undergone radiotherapy for the sole lesion have MIBG uptake...
  • Renal Insufficiency;
  • Active Infections;

The study team makes the final eligibility decision.

Where it's taking place

  • Chengdu, Sichuang, China
  • Chengdu, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 12 months and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chengdu, Sichuang, China; Chengdu, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.