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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clarity Pharmaceuticals Ltd
• Treatments: Copper

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 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. EBRT to both kidneys or a single functioning kidney within 12 months prior to the administration of 64Cu-SARTATE;

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

8. 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);

9. Known sensitivity or allergy to somatostatin analogues;

10. Previous PRRT;

11. Female participants who are pregnant or lactating;

12. Participants who are on hemodialysis;

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

14. Participants with uncontrolled infection(s);

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

16. 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.