{"id":47037,"date":"2025-12-04T13:52:54","date_gmt":"2025-12-04T11:52:54","guid":{"rendered":"https:\/\/www.incliva.es\/unidad-de-ensayos-clinicos-fase-i-oncologicos\/"},"modified":"2025-12-11T10:05:08","modified_gmt":"2025-12-11T08:05:08","slug":"phase-i-oncological-clinical-trials-unit","status":"publish","type":"page","link":"https:\/\/www.incliva.es\/en\/clinical-trials\/phase-i-oncological-clinical-trials-unit\/","title":{"rendered":"Phase I Oncological Clinical Trials Unit"},"content":{"rendered":"
Introduction<\/h5>\n

The Phase I Clinical Trials Unit began its activity in 2004, being a pioneer in Spain in the development of First-in-Human trials. It is linked to the Oncology Department of the Hospital Cl\u00ednico Universitario de Val\u00e8ncia and is located just 50 meters from the INCLIVA Foundation, making it the only hospital in Val\u00e8ncia that conducts Phase I clinical trials in cancer and one of the few accredited centers of this type at the national level.<\/p>\n

The Unit focuses on the development of new drugs through clinical trials and studies on the pathogenesis, prognosis and experimental therapies in solid tumors. A large part of its activity is oriented toward the development of international clinical trials promoted by major pharmaceutical companies. Phase I trials, in which investigational medication is administered for the first time to oncology patients, are carried out through the identification and selection of patients from the Oncology Department of the Hospital Cl\u00ednico Universitario de Val\u00e8ncia and from other referring centers, whose clinical characteristics match the target population of the investigational medicinal products. Unlike other units, studies in healthy subjects are not conducted.<\/p>\n

The innovative approach of the Unit combines molecular diagnosis and cancer treatment based on whole human genoma sequencing, which allows the identification of molecular alterations and the developmet of targeted therapies and personalized immunotherapy combinations. This approach drives the advancement of new therapies that are less toxic and more specific for each tumor type, thus consolidating the model of Personalized Precision Medicine. Some of the drugs evaluated in the Unit have already progressed to Phase II of clinical development.<\/p>\n

The Phase I and Experimental Treatment Unit has two main locations for patient care and for the work of the research and nursing staff. The 2nd and 3rd floors of the INCLIVA Health Research Institute, where activities related mainly to the coordination of Phase I clinical trials and studies in digestive, gynecological, genitourinary, head and neck cancer and melanoma are carried out; and the 8th floor of the Maternity Building of the Hospital Cl\u00ednico Universitario de Val\u00e8ncia, where clinical trials in breast cancer and lung cancer are conducted.<\/p>\n<\/div>

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Equipement<\/h5>\n

The second and third floors of INCLIVA\u2019s main headquarters are dedicated to oncology treatments. The Unit has specific rooms for the administration of treatments and the handling of biological simples, with advanced equipment that includes a -80 \u00b0C freezer, a -20 \u00b0C freezer, refrigerated benchtop centrifuges, conventional refrigerators, defibrillators, electrocardiography equipment, as well as 8 multiparameter monitors (blood pressure, heart rate and O\u2082 saturation), 7 double infusion pumps for medication and 7 gas heads (oxygen and vacuum). On the third floor there is also an ultrasound machine, 5 Philips vital signs monitors, 2 blood pressure monitors and 4 arches with 8 outlets\/heads and another 2 in the patient rooms.<\/p>\n

The area also has consultation rooms for patient care and offices for the work of nursing staff, data managers and administrative personnel. Recruitment exceeds 120 cases per year, with more than 65 patients treated simultaneously.<\/p>\n

All equipment is registered and subject to a preventive maintenance plan, which ensures anual control of calibrations and technical verifications in accordance with established quality standards.<\/p>\n<\/div>

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Clinical Team<\/h5>\n

The Phase I Oncological Clinical Trials Unit is directed by\u00a0Dr. Andr\u00e9s Cervantes<\/strong>, scientific director of the INCLIVA Health Research Institute, where he directs the Oncology Area, head of the Oncology Department of the Hospital Cl\u00ednico Universitario de Val\u00e8ncia and full professor at the Faculty of Medicine of the University of Valencia. The team is completed by 17 research nurses, 2 laboratory technicians and 1 CTAE, led by Inma Blasco; 10 Data Managers<\/em>, coordinated by Ignacio Casta\u00f1o; and 9 administrative professionals, coordinated by Yolanda de la Cruz. All of them have extensive experience in the development, management and implementation of clinical trials.<\/p>\n

Collaborating investigators<\/h5>\n

Desamparados Roda and Valentina Gambardella.<\/p>\n

Nursing team, laboratory technician and CTAE<\/h5>\n

Inma Blasco, Gloria Corredor, Matteo Stocco, Silvia Moreno, Mar\u00eda Calzadilla, Cecilia Ram\u00f3n, Paula Mart\u00ednez, Nuria Aguado, Mar\u00eda Montes de Oca, M\u00f3nica Ferrer Aguado, Grace Steffa, Jesmina Belenguer, Mar\u00eda Falco, Arantxa S\u00e1nchez Cosmo, Ana Vinatea, Cristian P\u00e9rez, Silvia Coret, Sara Rodr\u00edguez, Cristina Tebar, Ana Cos\u00edas and Elena Mieres.<\/span><\/p>\n

Data managers team<\/h5>\n

Nacho Casta\u00f1o, Ana Vercher, Beatriz L\u00f3pez, Sergio Romero, Alejandro Asturiano, Carmen Mart\u00ednez, Andrea Pascual, Nuria Roig, Rub\u00e9n Sanz and J\u00falia Soler.<\/span><\/p>\n

Administrative support team<\/h5>\n

Maribel G\u00f3mez. Iris Abad, Ainoa Vizuete,\u00a0 Paqui Fern\u00e1ndez, Lorena Saz, Paloma Campos, Enrique Castell\u00f3, Paranee Archavarat and Roberto San Leandro.<\/span><\/p>\n<\/div>

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Quality<\/h5>\n

The Phase I Oncological Clinical Trials Unit, committed to providing an adequate and efficient service to investigators, implemented and certified its quaility management system in 2019 in accordance with the requirements of the ISO 9001:2015 standard.<\/p>\n<\/div><\/div><\/div>