Inaugurated in June 2010, thanks to the support received from the ”la Caixa” Foundation, VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch is dedicated to complex clinical trials with drugs in early development (phase I and early phase II trials), focusing on novel targets. Occupying a total surface area of 1000 m2, our Unit is located within the General Area of the Vall d’Hebron University Hospital (HUVH), Vall d’Hebron Barcelona Hospital Campus.
This privileged environment with direct access to patients, coupled with VHIO’s translational approach to research and superb scientific framework, has enabled our Unit to rapidly establish itself as one of the few comprehensive facilities in Europe to rapidly transform latest discovery into benefits for patients. Our UITM – CaixaResearch incorporates a multidisciplinary team comprised of medical oncologists, clinical trial coordinators and data managers, nurses and nurse technicians, pharmacists, as well as administrative personnel.
By promoting tight connectivity between oncology care and research we establish novel treatment models for patients with highly selective drugs, and advance insights into tumor types and how to treat them in an individualized way – getting the right therapy to the right patient, at the right time. As the statistics show, we continue to do so for an increasing number of patients.
For another year, we have had to rapidly adjust to overcome the many challenges posed by the COVID-19 pandemic. All our efforts have focused on successfully maintaining our clinical research activities and continuing to include patients in our clinical trials. During 2021, our Unit participated in 207 ongoing phase I clinical trials, 27 of which are Basket trials (a 6% increase compared with 2020).
Our facilities, coupled with our multidisciplinary clinical teams, enable us to continue to expand our portfolio of phase I studies with 551 patients enrolled (a 6% increase compared with 2020). This year we opened 66 new trials; 5 as Baskets.
Research carried out at our Unit by VHIO’s Early Clinical Drug Development Group, directed by Elena Garralda, centers on the development of new drugs based on the molecular profile of each tumor as well as the optimization of treatment regimens using combinations of new agents with those that already exist.
Reflective of VHIO’s purely translational model, our studies are also linked to several research lines led by other VHIO groups, thus connecting molecular biology and optimal tumor models with pharmacology and innovative clinical research. VHIO scientists collaborate in our trials to facilitate biomarker development, a deep understanding of the mechanism of action, as well as research into mechanisms of cancer drug resistance.
We also participate in VHIO’s Molecular Prescreening Program, that performs molecular analyses of patients’ tumors to select the best possible treatment with the experimental therapeutics available. Thanks to our Cancer Genomics Group (PI: Ana Vivancos) and their development of existing applications including an n-Counter (Nanostring) platform, two digital PCR platforms (BEAMing Sysmex and ddPCR, BIO-RAD), and two NextGen Sequencers; MiSeq and HiSeq2500 (Illumina), we are equipped to perform faster and more precise mutational analyses of tumor suppressor genes as well as translocations and gene amplifications.
Excellent patient treatment and care as well as pioneering research is also made possible thanks to the collaboration of many other oncology professionals including our team of Clinical Research Oncology Nurses led by Ángeles Peñuelas, pathologists from the Vall d’Hebron University Hospital’s Molecular Pathology Department, radiologists and interventional radiologists, our Clinical Trials Office directed by Marta Beltran, Database Managers, VHIO’s Clinical Research Oncology Pharmacy Unit headed by Isabel Cidoncha, our Quality & Processes Unit headed by Gemma Sala, as well as many other healthcare specialists including dermatologists, cardiologists, and ophthalmologists.
- Early clinical drug development and translational research led by our UITM – CaixaResearch clinical investigators and VHIO researchers: expansion of our broad portfolio of promising novel anticancer therapies, across a balanced spectrum of studies, with special focus on first-in-human studies, novel-novel combinations, best-in-class compounds, and a new class of drugs.
- Perform complex trials such as organ dysfunction trials, Octopus as well as Basket studies, and link clinical research at this Unit to VHIO’s preclinical and translational projects. We also collaborate with various other partners involved in drug development and translational research.
- Genomic medicine trials in early drug development: perform molecular analysis of patients’ tumors in order to select the best possible treatment with the experimental treatments available, co-develop medical informatics applied to genomic medicine, and integrate preclinical and clinical research by incorporating novel drugs, new insights, and study design together with customized molecular diagnostics.
- Immunotherapy: our Unit’s Task Force in early drug development of immunotherapeutics and cell signaling focuses on second generation immunotherapies, including new cytokines, bispecifics, intratumoral agents, immunomodulatory, and immune checkpoint inhibitors and combinations, as well as translational research in immuno-oncology.
- We have performed some of the most complex phase I trials, including those focused on molecularly-selected patient populations (trials in complex molecularly-selected patient populations Basket/Octopus trials), as well as trials in immuno-oncology.
- We have expanded our expertise in drugs targeting developmental pathways, cell signaling (ERK, MET, FGFR, RET, NOTCH, NTRK), and immunotherapy (LAG3, TIGIT, OX40, CD40, IDO, arginase inhibitors and engineered antibodies).
- Developed by VHIO’s Cancer Genomics Group (PI: Ana Vivancos) we benefit from applications that enable us to generate faster results. These include an n-Counter (Nanostring) platform, two digital PCR platforms (BEAMing Sysmex and ddPCR, BIO-RAD), and two NextGen Sequencers; MiSeq and HiSeq2500 (Illumina). We also co-develop customized molecular tests for VHIO’s Molecular Prescreening Program, namely, disease-oriented mutation panels for our NGS platforms.
- We have established alliances with several pharma companies as the preferred site for testing their novel and most relevant therapies, including GlaxoSmithKline OCTC, Roche ImCORE, and Astra Zeneca/MedImmune Partner of Choice Network.
- Our investigators have successfully implemented the Basket of Baskets (BoB) trial which is a novel study in personalized medicine integrating cutting-edge molecular prescreening, the development of new diagnostic tests such as circulating DNA or Nanostring, with the testing of targeted therapies in populations of patients with identified molecular alterations and a high probability of benefiting from the selected treatments. This is an academic study, endorsed by the Cancer Core Europe (CCE) Consortium, and co-funded by pharmaceutical companies. We are engaged in ongoing and advanced negotiations with pharmaceutical companies to increase the number of modules.
- We have introduced Molecular Tumor Board meetings to discuss the most relevant genomic features of complicated cases and evaluate possible treatment options.
- We have launched an advanced cell-based therapy program, and are participating in several pharma sponsored trials to evaluate the role of TIL therapy. We are also exploring an academic TIL product in collaboration with Alena Gros (PI: VHIO’s Tumor Immunology & Immunotherapy Group).
- In collaboration with several other VHIO groups, we head our CaixaResearch Advanced Oncology Research Program (2020-2023), also supported by the ”la Caixa” Foundation.
Marta Beltran, Elena Garralda, Ángeles Peñuelas, Gemma Sala
Judith Balmaña, Joan Carles, Enriqueta Felip, Elena Garralda, Teresa Macarulla, Ana Oaknin, Cristina Saura, Josep Tabernero
CORE Phase I Investigators
Guzmán Alonso, Irene Braña, Vladimir Galvao, Julia Lostes, Honey K. Oberoi, Katerin Rojas, Omar Saavedra, María Vieito
Phase I Investigators
Daniel Acosta, Juan David Assaf, Iosune Baraibar, Maria Borrell, Ana Callejo, Jaume Capdevila, Susana Cedrés, Marc Diez, Elena Élez, Santiago Escrivá, Alejandro García, Carmen García, Macarena González, Francisco Grau, Jorge Hernando, Patricia Iranzo, Alexandre Martínez, Rafael Morales, Eva Muñoz, Alejandro Navarro, Mafalda Oliveira, Carolina Ortiz, Nuria Pardo, Francisco Javier Ros, Francesc Salvá, Nadia Saoudi, Cristina Suárez, Helena Verdaguer
Clinical Trials Office
Start Up Unit
Sílvia Pérez (Head)
Ignacio Carcela (Head)
Lead Study Coordinators
Eulàlia Aliende, Montserrat Moreno
Aitana Almodóvar (Sponsor dedicated), Eva Banús, Constancio Collado, Guillem Cunill, Núria Farràs, María López, Ana Matres (Sponsor dedicated), Elena Martínez, Sonia Martinez (Sponsor dedicated), Gemma Mur, Alejandro Pardines, Joel Puig, Laura Saucedo, Albert Teixidor (Sponsor dedicated)
Lead Data Entries
Eva del Castillo (external staff), Andrea Gómez (Sponsor dedicated), Lidia Martinez, Gerard Orriols, Sergio Pérez, Montserrat Pujadas, Isabel Rico, Jordi Romero, Inés Tejero (Sponsor dedicated), Gaudí Vall, Marta Vidigal
Clinical Trials Office Administrative Support
Nuria Carballo, Marc Palomar
Operational Research Nurses
Inés Depares, Andrea Martínez, Alba Silverio
Elena de Cabo, María Luisa Fargas, Marta Mate, Isabel Muñoz, Teresa Navarro, Gianmarco Russi
Mª Ascensión Clop, Mireia Hernández, Cristina Resina
Susana Flores, Araceli García-Platas
UITM - CaixaResearch Administrative Support (Schedulers)
Laura Abellán, Mª Teresa Mendoza, Noelia Moles, Marc Palomar
Head, Clinical Research Oncology Pharmacy Unit
Clinical Director of the Clinical Research Oncology Pharmacy Unit
Maria Queralt Gorgas
María Josep Carreras, Laura Maños
Montserrat Carreres, Carla Esteban, Celia Fernández, Lorena García, Patricia García, Pablo Latorre, Rocío Paucar, Pilar Rovira, Eugenia Serramontmany, Javier Varela
Romina Bellini, Esther Carabantes, Bryan Cárdenas, Angelica Cely, Ismael Delgado, Rafael Diaz, Ariadna Jabalera, Roser Klimt, Susana Mulet, Isabel Pérez, Marta Pozo, Alan Thompson, Silvia Torralba, Alexandre Valle, Noemi Visus