Department of Drug Development and Innovation (D3i)

The Department of Drug Development and Innovation (D3i) dedicated to early clinical trials was created in 2018 at Institut Curie under the leadership of Professor Christophe Le Tourneau. Its objectives? Increase the number of early trials, including patients, but also have better visibility among manufacturers. 

Carrying out an early trial (or Phase I trial) means testing for the first time in real conditions in patients a new molecule already tested in vitro or in animals or an already known drug, which will be used in a new strategy, for example in another type of cancer (new indication), or combined with another molecule (combination). Specifically, this involves ensuring the safety and feasibility of a new treatment and determining the optimal dose by testing it on a few dozen sick people, often relapsing in the case of cancer. 

These early trials are taking place in a brand new department at Institut Curie - the D3i, a unit headed by Professor Le Tourneau since 2018. This department offers close and multidisciplinary medical supervision of patients, with strict scientific protocols and specific management. These trials are carried out by a dedicated team (nurses, dedicated doctors, caregivers, etc.) within two Clinical Investigation Units (UIC) in Paris and Saint-Cloud. 

The main challenge in the fight against cancer today is precision medicine. Indeed, to combat the most resistant cancers, we must focus not only on the organ or tissue in which it develops, but also on the types of mutations that characterize it. Thus, the most innovative treatments, mainly targeted therapies and immunotherapies, are based on rare molecular alterations found in a small number of patients. In order to know which treatment to offer to a particular patient, it is therefore essential to establish the molecular profile of the tumor. 

At Institut Curie, all the experts collaborate closely to be able to search for these alterations and offer patients the most adapted and relevant treatments. At Institut Curie, all those involved in clinical research meet every week to establish the genetic map of the patient's tumor. This multidisciplinary consultation meeting titled "Molecular RCP", coordinated by Maud Kamal, Head of the Scientific Coordination Unit, is both the heart of D3i's activity and the reason why promoters (private or public research institutions, pharmaceutical companies) trust Institut Curie to carry out early trials. The objective of this multidisciplinary meeting (which brings together oncologists, pathologists, biologists, interventional radiologists, etc.) is to offer an alternative to patients whose tumors have metastasized, to those who no longer respond to conventional treatments, or to those who suffer from a rare form of cancer. Specifically, the samples and molecular analyses are carried out and then the biologists of the Pharmacogenetics and Somatic Genetics Units of Institut Curie interpret the results in order to determine if the tumor has an alteration, for which treatment is available as part of a clinical trial. This is done in close collaboration with the Diagnostic and Theranostic Medicine Division headed by Dr Anne Salomon and the genetics department with Prof. Ivan Bièche as the lead biologist. The D3i is actively participating in the deployment of the very high-speed sequencing platform SEQOIA piloted by the AP-HP, Institut Curie, and Gustave-Roussy.

• Caregivers and researchers are not the only ones involved in clinical research. Alongside them, biostatisticians design the methodology of clinical trials and analyze the large flow of data collected in databases thanks to data managers. Project managers participate in the development of studies and their budgetary monitoring and clinical research associates collaborate in data collection and monitoring of research protocols.
• The INCa has participated in the deployment of early trials in France since 2010 (logistical and financial support) by creating 15 INCa-certified early phase centers (CLIP²). Institut Curie certification was renewed in 2018. The HAS, for its part, issues a site authorization for the realization of Phase I trials of first administration in humans called "first-in-human". The D3i has been authorized by the HAS on the Paris site for the Phase I first-in-human trials.