Phase 1 Clinical Trials Unit (Early Clinical Drug Development Team – ECDD)

A research group dedicated to the clinical development of new drugs for the medical treatment of solid tumours.

The group’s primary focus is on the early stages of new drug development within Phase 1 or 2 clinical trials, including first-in-human studies, with the aim of providing guidance on their optimal clinical use in terms of safety and administration methods.

The drugs available in Phase I trials are intended for the treatment of pre-treated solid tumours for which there are no valid therapeutic alternatives, or tumours for which there is a strong rationale for targeting a molecular pathway directly involved in the pathogenesis. Phase I trials offer cancer patients the opportunity to gain early access to effective therapies that have the potential to improve their survival and quality of life. 

The therapies currently under investigation consist mainly of molecularly targeted drugs, antibody-drug conjugates and new immunotherapy drugs. In addition, a number of experimental protocols involving radioligands (Targeted Radionuclide Therapy – TAT) are being rolled out in collaboration with the Department of Nuclear Medicine.

The team works in close collaboration with the Clinical Trial Centre and the OM1 research laboratory, and is supported by dedicated research nurses. It also collaborates with the Clinical Cancer Immunotherapy and Innovative Therapies Unit for the treatment of inpatients and the management of toxicity.

Team members are regular participants in the institutional Molecular Tumour Board, which selects potential patients for inclusion in trials involving targeted therapies based on mutational analyses.

In accordance with AIFA Resolution 809/2015, certification has been obtained under the institutional Phase I Programme, which ensures that patients and treatments are managed in accordance with well-defined quality procedures.

The Foundation is a centre of excellence both nationally and internationally and participates in European networks such as Cancer Core Europe and the Gianni Bonadonna Foundation.