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