For the fourth time in a row, the Centre Baclesse is proud to be one of 16 centers in France to have been awarded the CLIP² (Centres Labellisé Phase Précoce) label by the French National Cancer Institute (INCa) for the period 2024-2029. This demanding label highlights the center's expertise and dynamism in adult oncology research. The Centre Baclesse joined the IHBN (Institut d'hématologie de Basse-Normandie) in 2015 and the onco-hematology department of the Centre Henri Becquerel in 2019 as partners in the CLIP² normand.
A guarantee of research excellence
This label, created in 2010, brings together investigator centers specialized in early-phase clinical trials within healthcare establishments (CHU, CLCC). INCa provides logistical and financial support to help these centers achieve the highest international standards of quality in early-phase clinical trials.
Early-phase trials are used to test the safety and efficacy of new drugs, in compliance with patient protection rules and international regulatory requirements.
"We are very proud to have been re-certified. Medical oncology is the medical specialty that has seen the most innovation in recent years, with new therapeutic approaches (such as immunotherapy and new chemotherapy methods combined with antibodies). Having a certified center in Normandy is a real opportunity for our patients, who can benefit from these pharmaceutical innovations at the earliest stage.
The CLIP2 label is a demanding distinction that reflects the quality and rigor of clinical research at the Baclesse Center. This label also highlights the excellence of the healthcare teams. Finally, it is a collective effort, including the trust that pharmaceutical companies place in us to test their new drugs and the commitment of doctors in the region who refer their patients to the Baclesse Center to give them access to these new therapies," explains Prof. Florence JOLY-LOBBEDEZ, Scientific Director of the Baclesse Center.
This initiative contributes to an overall increase in the number of new early-phase clinical trials opened each year at CLIP² centers, and in the number of patients included in these trials.
Clinical trials at the Centre Baclesse
Early-phase clinical trials represent the initial phases of drug development, prior to marketing. This gives patients access to innovative and promising drugs that do not yet have marketing authorization. Offering to take part in an early-phase clinical trial means offering an alternative to patients who no longer respond to conventional treatments, or who suffer from a rare form of cancer.
At the Centre Baclesse, the main early-phase trials offered to patients concern :
- New drugs with different mechanisms of action, including immunotherapy, targeted therapies, epigenetic drugs, nanoparticles, etc.
- Combinations of new drugs with each other or with radiotherapy
- Precision medicine treatments in which a drug is based on an identified molecular alteration. These drugs may be targeted therapies or immunotherapies.
A unit dedicated to research
Early-phase trials are conducted in a specialized unit, the IRIS Unit, located on the 2nd floor of the Baclesse Center.
Dr Mélanie DOS SANTOS, head of the IRIS unit, is delighted with the renewal of this label:
"The renewal of this certification will enable us to continue offering patients the most innovative treatments."
Patients enrolled in therapeutic trials are managed in this unit. The IRIS unit has :
- From its sampling center,
- Medical and paramedical consultation rooms
- 10 day hospital beds/places
- A team of dedicated professionals with expertise in clinical research
Between 2020 and 2022, 510 patients could benefit from innovative treatment(s) thanks to inclusion in one of the 170 early-phase trials opened in CLIP² Normand.
2024-2029: innovative perspectives
To meet the expectations of this accreditation, several areas of development are planned for the 2024-2029 period:
- Continued development of early-phase activities in solid tumors, notably in personalized medicine: For several years now, the Centre Baclesse has been offering patients genomic analysis of their cancer in order to propose therapies specifically targeting the anomalies found (as part of personalized cancer management). This analysis enables us to offer patients the opportunity to take part in precision medicine therapeutic trials targeting rare genomic anomalies, in partnership with industry or in collaboration with other CLIP2 centers.
- Strengthening collaboration with partner hematology sites in the use of CAR T-cells to offer access to MTIs (Molecules for Innovative Therapies) to patients with solid tumors.
- The structuring of nuclear medicine in Caen and Rouen, in association with translational research teams, should make it possible to offer new therapeutic alternatives to patients in the Normandy region, and to develop the emergence of new therapeutic modalities associating this promising technique.
- The pursuit of preclinical, clinical and translational research to evaluate new irradiation modalities, alone or in combination with targeted therapies, thanks to the establishment of France's 3rd proton therapy center in Caen and the presence of multidisciplinary research teams (biology, physics, etc.).
This demanding distinction reflects the values espoused by the Centre Baclesse, such as excellence in oncology research. It enables the Centre Baclesse to offer patients the most innovative treatments.
"I would like to congratulate all the teams on the renewal of the CLIP2 certification. This institutional project was carried out collectively and was very well received thanks to its innovative nature. We had a strong case, based in particular on molecular biology. The project is now moving into a new phase focused on Innovative Therapy Molecules (ITMs), marking a significant step forward in the development of cutting-edge treatments. The construction of a new building for the pharmacy aims to support this ambition by providing a space suitable for research and the manufacture of therapeutic vaccines. This development is part of the center's advanced research dynamic, which seems to hold great promise for the future," says Prof. Roman ROUZIER, Director General of the Baclesse Center.
