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Madrid, 18 May 2023-. According to the Spanish Clinical Trials Register (REEC), Spain authorised more than 900 clinical trials on medications in 2022. This figure shows a marked increase compared with previous years prior to the COVID-19 pandemic. Of the 900 registered and authorised trials, a third (328) are focused on medications for cancer treatment, making it the subject of the most studies after nervous system diseases and immune system pathologies.

Meanwhile, a third of the clinical trials underway are in the initial phases of research; in other words, the first stages of testing a drug on humans after confirming its effectiveness on animal models. This is known as Phase I, the most complex, but also essential for testing potentially effective molecules on course towards the administration of new drugs.   

As health professionals have made clear “for us research represents the most potent weapon in the fight against cancer. In this way, the Phase I Clinical Trials Unit is a further example of our commitment to science as part of our primary objective of eradicating this disease”, declared Dr. Fabio Franco, medical oncologist at the MD Anderson Cancer Center Madrid and one of the senior members of the Phase I Clinical Trials Unit of the MD Anderson Cancer Center Foundation Spain.

The doctor went on to point out that initiating a clinical trial involves a significant amount of work as “not only do we observe how a patient responds, but we also need to check that the patients match the criteria and have the opportunity to benefit from the treatment”.

Since opening in 2021, the Unit has recruited a total of 375 patients and is currently conducting 199 active trials in all phases, 54 of which are Phase I.  

Combinations of immunotherapy with new drugs which reinforce the effect of standard immunotherapy

As Dr. Franco states, staff at the Phase I Clinical Trials Unit staff are conducting trials of various phases. “We have trials from very early phases, Phase I clinical trials, in which we are administering certain molecules for the first time in humans in order to determine whether they are effective and safe in patients with specific types of tumour”. The work enables them to address a large number of tumours to observe “whether or not these new molecules demonstrate anti-tumour activity and determine the appropriate dose for these drugs and their effectiveness in controlling tumours”, says the doctor.  

The Unit is currently also conducting more advanced phase II and phase III trials on various drugs and tumour types, most significantly the drugs used in chemotherapy, immunotherapy or those targeted at oral therapies and specific receptors. According to Dr. Franco research work on “lung cancer, head and neck cancer and melanoma is currently a priority at the Unit”.

In terms of treatments, we would highlight the combinations of immunotherapy with new drugs. “We use now use immunotherapy as standard with many tumours, but these clinical trials, some of which are in the early phases I and II, will enable us to combine existing immunotherapy with new related drugs. What these molecules do is reinforce the effects we already know from standard immunotherapy”, explained the oncologist. 

DIPCAN continues to recruit patients with metastatic cancer

Among the most promising studies at the Phase I Clinical Trials Unit, is the DIPCAN study (Digitalisation and Handling of Personalised Medicine for Cancer). This study was initiated with the intention of improving clinical practice in the area of Oncology, promoting the development of personalised medicine through the integration of clinical and genomic data and radiographic imaging.     

DIPCAN is in the process of recruitment and hopes to obtain the participation of 2,000 patients. Participants in the study will have access to a visit from an oncologist specialising in clinical research who will collect data from each patient in a systematic manner. In addition, genomic sequencing of the tumour will be conducted on both the biopsy piece and a blood sample, the pathological anatomy images will be digitalised for each of the tumours and full body magnetic resonance will be performed which will include the patient´s radiological images. All the parameters will be anonymized and coded for storing, and will later be analysed via an artificial intelligence algorithm. 

The trial based on the DIPCAN Project data will seek to obtain a multidimensional understanding of cancer throughout the Spanish population. This information could lead to the development of health strategies for prevention, early diagnosis and more cost-effective treatment of the most prevalent tumours at a national level.  

The MD Anderson Cancer Center Foundation Spain is the promoter of the DIPCAN study, coordinated by Eurofins Megalab, and with the participation of Genomcore, Quibim, Pangaea Oncology, Artelnics and Atrys Health. DIPCAN is financed by the European Union through the Ministry of Economic affairs and Digital Transformation.