Study on 67Cu-SARTATE™ Therapy for Children with High-Risk, Relapsed, or Hard-to-Treat Neuroblastoma

Sponsor: Clarity Pharmaceuticals Ltd

Sponsor score: 0

ClinicalTrials ID:NCT04023331

Provider View

This clinical trial is testing a new treatment called 67Cu-SARTATE for children with high-risk neuroblastoma that has returned or is not responding to standard treatments. The study aims to find out if this treatment is safe and effective.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment called 67Cu-SARTATE in children with high-risk neuroblastoma, a type of cancer. The study will be conducted in two phases: a dose escalation phase to find the best dose, and a cohort expansion phase to test the treatment in more patients. The study will also include a long-term follow-up period of up to 36 months after the first dose, but in-person visits are not required during this time.

Description

This study is designed to test a new treatment called 67Cu-SARTATE for children with high-risk neuroblastoma, a type of cancer that is difficult to treat. The study will be conducted in two phases:

  1. Dose Escalation Phase: This phase will test different doses of 67Cu-SARTATE to find the safest and most effective dose. Up to four groups of patients will receive increasing doses. The safety of each dose will be monitored for six weeks after the first treatment cycle.

  2. Cohort Expansion Phase: Once the best dose is found, the study will expand to include more patients. These patients will receive at least two treatment cycles at the best dose. If the treatment is helping, patients may receive up to four cycles in total.

The study is adaptive, meaning it can change based on the results as it progresses. It is also personalized, with the number and timing of treatments tailored to each patient.

Participants will be followed for up to 36 months after their first dose to monitor long-term effects, but they do not need to attend in-person visits during this time.

Eligibility Criteria

Inclusion Criteria

  • Able to provide consent or have a parent/guardian provide consent if under 18.
  • Expected to live at least 12 more weeks.
  • Diagnosed with high-risk neuroblastoma or intermediate-risk neuroblastoma that has worsened.
  • Have not fully responded to standard treatments or cannot receive them.
  • Recovered from any side effects of previous treatments.
  • Have good liver and kidney function.
  • Have certain blood cell counts above specified levels.
  • Have a performance status score of 50 or higher, indicating they can carry out daily activities.
  • Have a stem cell product available for potential future use.
  • Agree to use birth control if of reproductive age.
  • Show uptake of 64Cu-SARTATE in scans before starting therapy.

Exclusion Criteria

  • Have a major organ disease that would make treatment unsafe.
  • Have another active cancer or had one in the past three years.
  • Have a history of heart failure or significant heart problems.
  • Plan to receive other cancer treatments shortly before starting the study treatment.
  • Have received certain cancer treatments recently, such as 131I-MIBG or radiation to the kidneys.
  • Have taken investigational drugs recently.
  • Have used somatostatin analogues recently or are allergic to them.
  • Have had previous peptide receptor radionuclide therapy.
  • Are pregnant or breastfeeding.
  • Are on hemodialysis.
  • Have a prolonged QT interval on an ECG.
  • Have an uncontrolled infection.
  • Have any condition that might interfere with the study.
  • Are 12 months or younger and would receive a radiation dose exceeding safe levels.

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