The University Hospital Group (GHU) APHP.Centre – Université Paris Cité, led by the Cancer Institute Paris CARPEM, is honored to announce its recent CLIP² (Early Phase Labeled Center) certification in adult oncology by the National Cancer Institute (INCa in French for Institut National du Cancer). The CLIP² is named CARPEM-ACTI (Clinical Access to Innovative Therapeutics).
CLIP² centers are research units located in healthcare institutions specializing in early-phase clinical research. The goals of this certification are to develop, structure, and increase the visibility of early-phase clinical research in France. The INCa (jointly with the French League Against Cancer for pediatric CLIP² centers) provides logistical support to certified institutions to promote this aim and elevate the quality of early-phase clinical trials in France to the highest standards. CLIP² centers design and conduct early-phase trials in accordance with patient protection rules and international regulations in the field. Among other commitments, they ensure that their clinical trial protocols and information leaflets are reviewed by patient committees prior to the initiation of trials.
The activities of CLIP² CARPEM-ACTI are distributed across three sites of the GHU, responsible for the departments managing the tumors treated at CLIP²:
- The CEPEC (Early-Phase Cancer Trial Center, Centre d’Essais Précoces en Cancérologie in french) at the European Hospital Georges Pompidou (referent: Dr Jacques MEDIONI):
- Medical oncology
- Thoracic oncology, Head and neck oncology
- The Clinical Reasearch Unit of Cochin Hospital (CCH) (referent: Pr Jérôme ALEXANDRE)
- Medical oncology
- Thoracic oncology, Head and neck oncology
- Endocrinology and Dermatology
- The Adult hematology department of Necker Hospital (NCK) (referent: Dr Laurent FRENZEL)
- Medical oncology
CARPEM-ACTI activity is coordinated by Dr. Jacques MEDIONI (HEGP), assisted by co-directors: Prof. Jérôme ALEXANDRE (CCH), Dr Laurent FRENZEL (NCK) and Prof. Olivier HERMINE (NCK).
The leadership of the triumvirate of directors of CLIP² aims to foster a culture of innovation and interdisciplinary collaboration, from basic science to patient care and vice versa. The scientific project CLIP² CARPEM-ACTI is integrated into the scientific program of the Cancer Institute Paris CARPEM and aims to provide rapid access to new treatments for solid and hematological tumors. The clinical research project is structured into five main axes:
Axis 1 : First-in-Human trials
Referents : Dr J Medioni (HEGP), Dr L Frenzel and Pr O Hermine (NCK)
First-in-Man (FIM) axis corresponds to the expertise necessary to conduct trials involving the first exposure of a cancer patient to experimental drugs. These studies typically include a limited number of patients, with particular attention paid to safety and pharmacovigilance issues. Following the approval to conduct FIM trials in 2015 and an audit in 2023, CEPEC (main CLIP² site) has conducted five FIM clinical trials in the past three years. The NCK site has also been authorized to conduct FIM studies for over 10 years, and this authorization was renewed in October 2022.
Axis 2 : Immune Checkpoints Inhibitors
Referents : Pr S Oudard (HEGP), Pr E Tartour (HEGP)
Immune checkpoint inhibitors axis encompasses early trials focused on drugs that act on the immune system to treat cancer patients. It is particularly active, especially in treating tumors eligible for immunotherapy usually managed at the Cancer Institute Paris CARPEM (kidney and lung cancers), as well as hematological malignancies like EBV-related tumors. This axis particularly benefits from the GHU’s expertise in immune biological monitoring and oncology specialties, as these therapies can induce side effects in multiple organs.
Axis 3 : Vectorized Internal Radiotherapy
Referent : Pr J Clerc (CCH)
Vectorized Internal Radiotherapy axis is implicated in various projects with new specific tracers against cancer. Here are examples of developed projects:
- Studies on PSMA_177Lu therapy, promoted by the industry for prostate cancers.
- An industrial study on CXCR4_68Ga as a diagnostic tracer in hematology (lymphomas).
- An academic study on CXCR4_68Ga in adrenal adenomas.
- An academic project in collaboration with CEA on the development of a new metabolic tracer using a fluorinated derivative of glutamine.
- A synthesis project on PSMA-177Lu for pre-therapeutic dosimetry to monitor high activity doses and complement external radiotherapy.
Axis 4 : Targeted molecular therapies
Referents : Pr J Alexandre (CCH), Pr H Blons (HEGP)
Cet axe se concentre les essais étudiant de nouveaux composés qui ciblent les voies moléculaires pathologiques impliquées dans le développement ou la progression du cancer. Pour recruter les patients de façon optimale, le CLIP2 bénéficie des résultats du séquençage extensif (séquençage du génome entier et séquençage du transcriptome) réalisé sur la plateforme de génomique de l’APHP-Centre et au sein du SIRIC CARPEM, et avec les réunions multidisciplinaires des tumeurs moléculaires de SeqOIA. La plateforme CARPEM (mise en place par l’Institut du Cancer Paris CARPEM) a une activité de diagnostic somatique (caractérisation des tumeurs) et de prédisposition aux cancers.
This axis focuses on trials studying new compounds that target the pathological molecular pathways involved in cancer development or progression. To optimally recruit patients, CLIP² benefits from extensive sequencing results (whole genome sequencing and transcriptome sequencing) carried out on the genomic platform of APHP-Centre and within the SIRIC CARPEM, along with multidisciplinary meetings for molecular tumor discussions at SeqOIA. The CARPEM platform (established by the Cancer Institute Paris CARPEM) has a somatic diagnosis activity (tumor characterization) and cancer predisposition assessment.
Axis 5 : Interventional radiology
Referents : Pr O Pellerin (HEGP), Pr J- M Correas (NCK), Pr A Dohan (CCH)
The early-phase research program of this axis will cover four main aspects of interventional radiology:
- Delivery of therapeutic compounds (drugs, radioactive elements, MTIs, or implantable smart medical devices, whether through intra-arterial or percutaneous injection)
- Evaluation of combination therapies involving ablation and intravenous/intra-arterial chemotherapy
- Implementation of robotics in interventional radiology
- Development of a method for controlling analgesia through endovascular denervation