Approval received for proof-of-concept early oncology clinical trial: “Study to investigate the pharmacodynamic effects of single ascending dose of imatinib in healthy subjects using an adaptive Bayesian design (EU CT 0023-504958-35-00)”.
CHDR is breaking new ground with an integrative oncology drug development program that aims to use the same biomarkers in both healthy volunteers and patients.
By using an adaptive Bayesian study design and advanced trial biomarker methodology, the team focuses on early pharmacodynamic readouts instead of following a safety/tolerability-based dose escalation. This novel integrative approach has the potential to accelerate the drug development process in oncology and make early assessment of proof-of-pharmacology more efficient. Together with extensive biomarker exploration and the use of bone marrow analysis the study paves the way for safer and more effective dosing strategies in patient populations. The study is in alignment with relevant regulatory developments, such as the FDA’s initiative to reform the dose optimization and dose selection paradigm in oncology drug development (Project Optimus). This refinement of early drug development in oncology will expedite timelines of clinical trials, reduce costs and critical time to treat patients.
We are proud of our interdisciplinary collaboration with both industry and academia and are committed to further developing an integrative approach for oncology together with our partners.
Stay tuned for next year!
Read more about this approach and recent articles here:
Patients and healthy volunteers in an integrative approach to drug development in oncology
Integration of healthy volunteers in early phase clinical trials with immuno-oncological compounds.
Healthy volunteers in first-in-human oncology drug development for small molecules.
