Clinical Trials /

67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma

NCT04023331

Description:

The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma
  • Official Title: 67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma: A Multi-center, Dose-escalation, Open-label, Non-randomized, Phase 1-2a Theranostic Clinical Trial

Clinical Trial IDs

  • ORG STUDY ID: CL04
  • NCT ID: NCT04023331

Conditions

  • Neuroblastoma

Interventions

DrugSynonymsArms
67Cu-SARTATECu-67 SARTATE, copper 67 SARTATE67Cu-SARTATE
64Cu-SARTATECu-64 SARTATE, copper 64 SARTATE67Cu-SARTATE

Purpose

The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.

Detailed Description

      This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion
      phase. Dose escalation will be completed using a modified 3+3 study design with up to 4
      Cohorts of increasing doses in MBq/kg. Pre-defined Dose Limiting Toxicities will be monitored
      for 6 weeks post administration of 67Cu-SARTATE. Once either the MTD for a single
      administration of 67Cu-SARTATE is established, or Cohort 4 has been completed, the study will
      be expanded to enroll an additional 10 subjects who will receive up to 2 therapy cycles of
      67Cu-SARTATE at the MTD dose level.
    

Trial Arms

NameTypeDescriptionInterventions
67Cu-SARTATEExperimental64Cu-SARTATE - patients will receive a bolus injection of 64Cu-SARTATE during screening, and following each 67Cu-SARTATE Therapy Cycle at a rate of 2.0 MBq/kg. 67Cu-SARTATE - In the dose escalation phase, patients will receive a single administration of 67Cu-SARTATE as a slow IV infusion (dose will be determined based on cohort allocation). In the expansion phase, patients will receive up to 2 administrations of 67Cu-SARTATE a the MTD level as a slow IV infusion.
  • 67Cu-SARTATE
  • 64Cu-SARTATE

Eligibility Criteria

        Inclusion Criteria:

          1. Participant is able and willing to provide informed consent (≥18 years), or informed
             consent is obtained by the parent or legal guardian for minor participants, with the
             minor providing age appropriate assent, according to local law and regulations;

          2. Life expectancy ≥ 12 weeks;

          3. Known high-risk neuroblastoma with failure to respond to standard therapy (combination
             chemotherapy with or without radiation and surgery), or development of PD at any time;

          4. Adequate recovery from acute toxic effects of any prior therapy, as deemed by the
             Investigator or treating Sub-Investigator;

          5. Adequate liver function as defined by the following laboratory values obtained within
             28 days prior to administration of 64Cu-SARTATE: Aspartate aminotransferase (AST) and
             alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN);

          6. Adequate renal function;

          7. Adequate laboratory parameters: Absolute neutrophil count > 1.0 x 109/L; Platelet
             count > 50 x 109/L; Serum bilirubin <1.5 x ULN;

          8. Karnofsky or Lansky performance status ≥50;

          9. All participants must have a hematopoietic stem cell product available (minimum CD34+
             cell dose is ≥2 x 106 cells/kg);

         10. Sexually active participants of reproductive potential must practice an effective
             method of birth control while participating on this study, to avoid possible damage to
             the fetus. Abstinence is considered acceptable;

         11. 64Cu-SARTATE uptake on the 4 hour scan (SUVmax) of any lesion equal to or higher than
             that of the liver in order to move on to the therapy phase of the study.

        Exclusion Criteria:

          1. Participants with disease of any major organ system that would compromise their
             ability to tolerate therapy, as deemed by the Investigator or treating
             Sub-Investigator;

          2. Any other active malignancy, or a history of prior malignancy within the past 3 years;

          3. History of cardiac failure as evidenced by: dyspnea at rest, exercise intolerance,
             oxygen requirement, clinically significant cardiac dysfunction;

          4. Planned administration of chemotherapy, anti-cancer cytokine therapy, immunotherapy,
             radiotherapy including radiopharmaceuticals or other investigational agents within 2
             weeks prior to the administration of 64Cu-SARTATE and 4 weeks prior to the
             administration of 67Cu-SARTATE;

          5. Administration of therapeutic dose of 131I-MIBG within 8 weeks prior to the
             administration of 64Cu-SARTATE;

          6. Administration of any investigational agents within 28 days prior to administration of
             64Cu-SARTATE;

          7. Treatment with long acting somatostatin analogues (administered within 28 days prior
             to the administration of 64Cu-SARTATE), or short acting somatostatin analogues
             (administered within 24 hours prior to the administration of 64Cu-SARTATE);

          8. Known sensitivity or allergy to somatostatin analogues;

          9. Previous PRRT;

         10. Female participants who are pregnant or lactating;

         11. Participants who are on hemodialysis;

         12. QTc interval ≥ 0.45 seconds as measured by Screening ECG;

         13. Participants with uncontrolled infection(s);

         14. Any medical condition which the Investigator feels may interfere with the procedures
             or evaluations of the study;

         15. Participants 12 month and younger will be excluded from cohorts where the planned
             single or cumulative administered activity is modelled to deliver a radiation dose to
             the marrow that exceeds 2 Gy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose of 67Cu-SARTATE
Time Frame:6 weeks
Safety Issue:
Description:MDT as determined by cohort observations of DLTs

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Clarity Pharmaceuticals Ltd

Last Updated

May 24, 2020