Introduction
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 Clínico Universitario de València and is located just 50 meters from the INCLIVA Foundation, making it the only hospital in València that conducts Phase I clinical trials in cancer and one of the few accredited centers of this type at the national level.
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 Clínico Universitario de València 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.
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.
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 Clínico Universitario de València, where clinical trials in breast cancer and lung cancer are conducted.
Equipement
The second and third floors of INCLIVA’s 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 °C freezer, a -20 °C freezer, refrigerated benchtop centrifuges, conventional refrigerators, defibrillators, electrocardiography equipment, as well as 8 multiparameter monitors (blood pressure, heart rate and O₂ 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.
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.
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.
Clinical Team
The Phase I Oncological Clinical Trials Unit is directed by Dr. Andrés Cervantes, scientific director of the INCLIVA Health Research Institute, where he directs the Oncology Area, head of the Oncology Department of the Hospital Clínico Universitario de València 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, coordinated by Ignacio Castaño; 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.
Collaborating investigators
Desamparados Roda and Valentina Gambardella.
Nursing team, laboratory technician and CTAE
Inma Blasco, Gloria Corredor, Matteo Stocco, Silvia Moreno, María Calzadilla, Cecilia Ramón, Paula Martínez, Nuria Aguado, María Montes de Oca, Mónica Ferrer Aguado, Grace Steffa, Jesmina Belenguer, María Falco, Arantxa Sánchez Cosmo, Ana Vinatea, Cristian Pérez, Silvia Coret, Sara Rodríguez, Cristina Tebar, Ana Cosías and Elena Mieres.
Data managers team
Nacho Castaño, Ana Vercher, Beatriz López, Sergio Romero, Alejandro Asturiano, Carmen Martínez, Andrea Pascual, Nuria Roig, Rubén Sanz and Júlia Soler.
Administrative support team
Maribel Gómez. Iris Abad, Ainoa Vizuete, Paqui Fernández, Lorena Saz, Paloma Campos, Enrique Castelló, Paranee Archavarat and Roberto San Leandro.
Quality
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.
Head
andres.cervantes@uv.es
Address
INCLIVA
Avenida Menéndez Pelayo 4 accesorio, planta 2
46010 Valencia