Bispecific PSMAxCD3 Antibody CC-1 in Patients With Squamous Cell Carcinoma of the Lung
Status:
Not yet recruiting
Trial end date:
2025-01-31
Target enrollment:
Participant gender:
Summary
This trial is a phase I study in patients with metastatic non-small-cell lung cancer (NSCLC)
after failure of second 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 tumor cells of squamous cell carcinoma of
the lung (SCC) as well as to tumor vessels of SCC, 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 dose-escalation 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). 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.