CHDR aims to break new ground in early stage clinical drug research. While our work spans a wide range of medical disciplines, early-phase immuno-oncology drug development is a special interest of ours. The rapidly changing field of immuno-oncology and the increasing complexity of trials in this area call for an expert approach.
Early-phase immuno-oncology trials
Our in-house oncology specialists coordinate with a broad network of clinical experts and dedicated research centres. Given the distinctive nature of early-phase oncology trials, the oncology teams at CHDR strive to align study design as closely as possible with clinical needs. Early-phase immuno-oncology trials at CHDR primarily involve healthy volunteers, but we are also ready to accommodate patient studies.
A tailored approach
Adequate dose selection is essential in early-phase drug development. In designing early-phase immuno-oncology trials, we follow a multifactorial decision process to arrive at a randomised dose-ranging study. Rather than finding the maximum tolerated dose, our trials aim to find the biologically active dose. Defining a biologically active dose in healthy volunteers enables us to design subsequent patient studies with an increased chance of clinical effects, as well as a lower risk of suboptimal exposure.
Finding the biologically active dose of anticancer drugs in early-phase trials is intertwined with determining relevant biomarkers. We strive to identify the optimal biomarker(s) to track treatment effects in early phases. Our bedside biomarker laboratory is known for its tailored cellular pharmacodynamic assays (cell sorting, flow cytometry, ex vivo cell incubations) and is fully equipped to quantify biomarkers both in and ex vivo. At CHDR, biomarker assays can be complemented by a unique selection of functional test batteries, including NeuroCart®, PainCart® and DermaToolbox®.