Investor Presentaiton
SAR-bisPSMA diagnostics
Two Phase III trials required for registration in prostate cancer: one in the pre-definitive treatment and one in the
biochemical recurrence (BCR) setting. Clarity is expecting to commence these registrational trials in 2023.
PROPELLER
PROPELLER: PET Imaging of participants with confirmed prostate cancer
Compares 64CU SAR-bisPSMA to 68Ga PSMA-11 (Approved in the US and
Australia) in participants with untreated prostate cancer who are
planned for radical prostatectomy
Trial design
Phase I multi-centre, blinded review, dose ranging, non-randomised
study in 30 patients across Australia.
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COBRA
COBRA: Copper-64 SAR-bisPSMA in BCR prostate cancer
Investigates the safety and tolerability of 64CU-SAR-bisPSMA as well as its
ability to correctly detect recurrence of prostate cancer in participants
with BCR of prostate cancer following definitive therapy
Trial design
Phase I/II multi-centre, single arm, non-randomised study in up to 50
patients across the US
Status
Screening +
68Ga PSMA-11
scan
Assignment to
dosing cohorts
1-3
64CU SAR-
bisPSMA scan
Reached 50% recruitment in December 2021
Next milestones
Recruitment complete in Q2 2022
Topline data in Q4 2022
CLARITY
2014 M
Status
Suspected
Assessed
BCR based on
PSA, negative on
64CU SAR-
bisPSMA
against
composite
conventional
imaging
scan (@~1h &
24h)
reference
standard
First patient dosed in April 2022, recruitment ongoing
Next milestone
•
50% recruitment in Q3 2022
PROPELLER clinicaltrials.gov identifier: (NCT04839367)
COBRA clinicaltrials.gov identifier: (NCT05249127)
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