the Bispecific PSMAxCD3 Antibody CC-1 in Patients With Castration Resistant Prostate Carcinoma
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
This trial is a first in human (FIH) study in patients with castration resistant metastatic
prostate cancer (CRPC) after failure of third-line therapy aiming to evaluate safety and
efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity developed within
DKTK. CC-1 binds to human prostate-specific membrane antigen (PSMA) on prostate cancer cells
as well as to tumor vessels of CRPC, 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 expected fewer side effects. Together
with preemptive IL-6 receptor (IL-6R) blockade using tocilizumab, this allows for application
of effective bsAb doses with expected high anticancer activity. The study comprises two
phases. The first phase is a doseescalation phase with concomitant prophylactic application
of tocilizumab to evaluate the maximally tolerated dose (MTD) of CC-1. This is followed by a
dose-expansion phase (also with prophylactic IL-6R blockade using tocilizumab), as this
approach has been shown to be efficient and beneficial for patients. A translational research
program comprising, among others, analysis of CC-1 half-life and the induced immune response
as well as molecular profiling in liquid biopsies will serve to better define the mode of
action of CC-1 and to identify biomarkers for further clinical development.