Clarity Pharmaceuticals Ltd. announced that it has completed cohort 1 and advanced to cohort 2 in the 64 Cu/67 Cu SARTATETM Neuroblastoma trial (CL04 trial). The SRC assessed the data from cohort 1 in three patients where no DLTs have occurred and recommended to progress the trial to cohort 2, without modification, increasing the dose from 75MBq/kg to 175MBq/kg body weight. Additional therapy cycles of 67 Cu SARTATETM have been requested by clinical sites and are being administered to patients in cohort 1 in the CL04 trial.

As part of the trial, patients have also received multiple doses of 64 Cu SARTATETM for the imaging of tumours to assess disease localisation and eligibility for therapy. At the time of the SRC meeting, no adverse events had been reported relating to the administration of 64 Cu-SARTATETM. The CL04 trial is a theranostic (diagnosis and therapy) trial in paediatric patients with high-risk neuroblastoma (NCT04023331) .

It is a multi-centre, dose-escalation, open label, non-randomized, Phase 1/2a clinical trial with up to 34 patients conducted at five clinical sites in the US. 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 mortality. 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%.