Description:
The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.
The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.
Recruiting
Phase 1/Phase 2
Drug | Synonyms | Arms |
---|---|---|
67Cu-SARTATE | Cu-67 SARTATE, copper 67 SARTATE | 67Cu-SARTATE |
64Cu-SARTATE | Cu-64 SARTATE, copper 64 SARTATE | 67Cu-SARTATE |
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 2 therapy cycles of
67Cu-SARTATE at the MTD dose level.
Name | Type | Description | Interventions |
---|---|---|---|
67Cu-SARTATE | Experimental | 64Cu-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 2 administrations of 67Cu-SARTATE a the MTD level as a slow IV infusion. |
|
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | N/A |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Maximum Tolerated Dose of 67Cu-SARTATE |
Time Frame: | 6 weeks |
Safety Issue: | |
Description: | MDT as determined by cohort observations of DLTs |
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Clarity Pharmaceuticals Ltd |
August 3, 2021