Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
This trial is a phase I open-label, single center study designed to evaluate the safety,
tolerability and preliminary efficacy of the bispecific prostate specific membrane antigen
(PSMA) and cluster of differentiation protein 3 (CD3) antibody CC-1 in men with biochemical
recurrence (BCR) of prostate cancer (PC). The PSMA binder in CC-1 reacts with tumor cells and
also binds to tumor vessels, thereby allowing for a dual mode of anti-cancer action. CC-1 was
developed in a novel format, which not only prolongs serum half-life, but most importantly
reduces off-target T-cell activation with accordingly reduced side effects. The study entails
a part I (dose escalation part) to identify the maximally tolerated dose of CC-1, which then
will be further evaluated in part II of the study (dose expansion part). After application of
two low doses as safety steps in the first cycle, CC-1 will be applied twice weekly for three
consecutive weeks within 4 week cycles as a short-term intravenous infusion (3 hours). The
planned trial ultimately shall define the recommended phase II dose (RP2D) of CC-1 in the
disease setting of BCR of PC.