Investor Presentaiton
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SARTATE™M Clinical trials
CL04
SARTATE™M CLO4: 67CU-SARTATE™M Peptide Receptor Radionuclide
Therapy Administered to Pediatric Patients With High-Risk, Relapsed,
Refractory Neuroblastoma
64Cu/67 CU SARTATET Phase I/lla trial in high-risk neuroblastoma in the
US with up to 34 patients
Trial design
Multi-centre, dose-escalation, open label, non-randomised,
theranostic clinical trial
Status
Cohort 1 complete, no safety issues
Cohort 2 in the therapy trial in progress
Neuroblastoma is one of the most aggressive childhood cancers
800 new cases each year in the US and the most common
cancer in infants
Neuroblastoma accounts for approximately 13% of paediatric
cancer mortalities
Approximately 84% of neuroblastomas express SSTR2
DISC
DISCO: Diagnostic Imaging Study of Copper-64 SARTATE using PET on
patients with known or suspected NETS
•
Assesses the performance of imaging agent 64CU SARTATE™M in
participants with known or suspected gastroenteropancreatic NETs as a
potential new way to help diagnose and manage NETS
Aims to capture and highlight the significant advantages of the longer
half-life (12.7 hours) of copper-64, related to imaging and product
supply which are relevant to Clarity's entire pipeline of products in
development
Trial design
°
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Phase II multi-centre, single arm, non-randomised, blinded-review
study in up to 63 participants
Compares diagnostic performance of 64 CU SARTATETM at 4 and 20
hours to the current standard of care, 68 Ga DOTATATE, at 1 hour
Status
Currently recruiting at four sites with 64CU SARTATEM manufactured
centrally in Australia
CLARITY
2014 ME
CL04 ClinicalTrials.gov identifier: NCT 04023331
DISCO ClinicalTrials.gov identifier: NCT 04438304
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