No issues were observed during the administration of 67Cu SARTATE and the participant continues to be followed for further safety and efficacy assessments as per protocol. The product administered to the participant was the first patient dose manufactured using copper-67 produced by
The CL04 trial (NCT04023331)1 is a theranostic trial evaluating 64Cu/67Cu SARTATE for diagnosis and treatment of high-risk neuroblastoma, an aggressive childhood cancer. It is a multi-centre, dose-escalation, open label, non-randomised, Phase I/IIa clinical trial with up to 34 participants conducted across eight clinical sites in the US.
Cohort 4 is the highest dose level cohort in the dose escalation phase of the CL04 trial. The aim of the dose escalation phase is to determine the optimal dose of 67Cu SARTATE that can be safely administered. Once the optimal dose is established, the trial will progress to the dose expansion phase where an additional 10 participants will receive at least 2 administrations of 67Cu SARTATE. Participants who demonstrate therapeutic benefit may be offered up to 4 therapy cycles of 67Cu SARTATE in total.
Some participants in the earlier cohorts have received additional therapy cycles of 67Cu SARTATE in addition to the single therapy cycle administered under the dose escalation phase of the CL04 trial. These subsequent therapy cycles are strictly contingent on the investigators' assessment that the participant is demonstrating therapeutic benefit after the first dose.
Clarity's Executive Chairperson, Dr
'High-risk neuroblastoma is a devastating cancer that predominantly affects children and has incredibly poor prognosis as there are few treatment options available to these patients with late-stage disease. At Clarity, we are dedicated to actively progressing the CL04 trial in the hope that our SARTATE product will deliver significant improvements to the diagnosis and treatment of children with this insidious disease in need of highly effective treatments.'
The first 67Cu SARTATE dose, administered in cohort 4 of the CL04 trial, was manufactured using copper-67 produced by
About SARTATE
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), including neuroblastoma and neuroendocrine tumours (NETs). Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu SARTATE) or copper-67 (67Cu) for therapy (67Cu SARTATE).
In 2020, the
64Cu SARTATE and 67Cu SARTATE are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the
About Neuroblastoma
Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality2. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%3.
Highlights
First participant of cohort 4 of the theranostic CL04 trial investigating 64Cu/67Cu SARTATE in neuroblastoma has been treated at the highest dose cohort of 375MBq/kg body weight.
Cohort 3 was successfully completed in 3 participants with neuroblastoma who received therapy with 67Cu SARTATE at a dose of 275MBq/kg body weight.
Additional therapy cycles of 67Cu SARTATE have been requested by clinical sites and administered to participants in the dose escalation phase of the trial.
About
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing TCTs based on its SAR technology platform for the treatment of children and adults with cancer.
About
Contact:
Dr
Tel: +61 (0)413 871 165
Email: ataylor@claritypharm.com
(C) 2023 Electronic News Publishing, source