Description
The Phase I Clinical Unit is part of the Advanced Clinical Research and Innovation Directorate, within the Scientific Directorate, and works in close collaboration with the Health Management, General Management, and all clinical units of the Institute.
The Unit plays a central role in advancing oncology research, contributing to the development of new drugs while ensuring clinical activities according to the principles of Good Clinical Practice (GCP) and comply with national and international regulations.
Its mission is to provide patients with access to the most innovative cancer therapies, translating preclinical research findings into practical and safe treatments.
Self-certified by AIFA in 2018 (code FI/171), the Unit is organized according to national and international regulatory standards and has advanced technological and professional resources that enable it to conduct Phase I trials with high levels of safety, quality, and regulatory compliance.
The Phase 1 Clinical Unit includes 8 beds dedicated to patients involved in Phase I studies, distributed between the Day Hospital and the Oncology Inpatient Ward. The clinical activity is supported by the Phase I Laboratory Unit (code FI/172), also AIFA self-certified as of 2018, which expertly handles biological samples and all analyses required for early-phase studies.
Responsibility
The Phase I Unit coordinates the entire clinical trials pathway, from assessing study feasibility to establishing operating procedures, staff training, and ongoing monitoring of patient safety and clinical outcomes.
Main responsibilities include:
- Management of clinical pathways and any emergencies.
- Compliance with AIFA 809/2015 requirements and maintenance of the quality system.
- Management and traceability of experimental drugs.
- Filing and oversight of regulatory documentation.
- Organization of information flows with sponsors and CROs.
- Supervision of data monitoring, entrusted to Clinical Research Coordinators dedicated to each therapeutic area.
The Unit also works in close synergy with the following divisions:
Innovative Therapies
“Innovative therapies” are defined as next-generation approaches that complement or surpass traditional cancer treatments, including:
- Immunotherapy: stimulates or modulates the immune system to recognize and attack cancer cells
- Targeted therapy: act on specific biological mechanisms of the tumor
- Cell therapies: cells harvested and modified in the laboratory to selectively target disease
- New antibodies, bispecific antibodies, and antibody–drug conjugates (ADCs): enable drug delivery directly into tumor cells, for precise treatment
- Cancer vaccines: designed to stimulate a therapeutic or preventive immune response
- Radioconjugates: combine an antibody with a radioactive isotope to focus radiation on tumor cell, while minimizing exposure to healthy tissue.
Dedicated spaces, advanced monitoring technologies , and specialized staff allow these new therapies to be developed efficiently, providing patients with access to cutting-edge treatments from the earliest stages of clinical experimentation.
Contact
The Phase I Clinical Unit serves ad the primary point of contact for sponsors, CROs, ethics committees, internal investigators, and Institute facilities involved in early-phase studies.
The Unit can be contacted for inquiries regarding:
- Submission and activation of Phase I studies
- Feasibility assessment
- Operational coordination
- Access to procedures and study protocols
Write to:
- Active clinical trials: ufficio.trials@ircc.it
- Activation of new clinical trials: clinicalstudy.startup@ircc.it
