Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer — ProSperACC-1  

Prostate Cancer Recurrent Clinical Trial

Official title: Phase I Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Prostate Cancer Recurrent
• Prostatic Neoplasms
• Recurrence

• NCT number: NCT05646550
• Study type: Interventional
• Source: University Hospital Tuebingen
• Contact: Walz
• Phone: +49(0)707129
• Email: kketi@med.uni-tuebingen.de
• Status: Recruiting
• Phase: Phase 1
• Start date: November 11, 2022
• Completion date: December 2025