Portal de recerca
Estudio con aumento escalonado y ampliación de la dosis para evaluar la seguridad y la farmacocinética del XB002 en monoterapia y politerapia en pacientes con tumores sólidos localmente avanzados o metastásicos inoperables.
Dades bàsiques
- Protocol:
- XB002-101
- EURDRACT:
- 2021-006543-10
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2023
- Any de finalització:
Objectius del projecte
Objetivo Principal: Cohort-Expansion Stage (Single-Agent and Combination Therapy Cohorts): Primary: • To evaluate the preliminary efficacy of XB002 when administered alone and in combination therapy by estimating the ORR per RECIST 1.1 as assessed by the Investigator Objetivos Secundarios: • Evaluar la seguridad y tolerabilidad del XB002 cuando se administra en monoterapia y politerapia. • Evaluar más en profundidad la FC del XB002 (anticuerpos conjugados con carga útil), los anticuerpos totales (anticuerpos conjugados y no conjugados) y la carga útil libre tras la administración i.v. en monoterapia y politerapia. • Evaluar la inmunogenicidad del XB002. • Evaluar la actividad antitumoral del XB002 en monoterapia y politerapia, medida mediante la DdR y la SSP de acuerdo con los criterios RECIST 1.1 evaluada por el investigador. • Evaluar la actividad antitumoral del XB002 en monoterapia y politerapia determinada mediante la TRO, la DdR y la SSP según los criterios RECIST 1.1 evaluada por un comité de radiología independiente con enmascaramiento (CRIE) en cohortes determinadas. • Evaluar la supervivencia global. • Evaluar los cambios en los marcadores tumorales con respecto al inicio en indicaciones tumorales seleccionadas.
Documents
- No hi ha documents
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
[[Tranaslated article]]Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.
López DF; (...); Ortiz-Romero, P. L.
Article. 10.1016/j.ad.2022.11.013. 2023
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.
Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.12.007. 2025
[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.
Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.09.006. 2024
A comparison of whole-mount and conventional sections for pathological mesorectal extension and circumferential resection margin assessment after total mesorectal excision
Giner, Francisco; (...); Garcia-Granero, Eduardo
Article. 10.1016/j.ciresp.2024.01.008. 2024
A comparison of whole-mount and conventional sections for pathological mesorectal extension and circumferential resection margin assessment after total mesorectal excision.
Giner, Francisco; (...); Garcia-Granero, Eduardo
Article. 10.1016/j.cireng.2024.01.008. 2024
A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.
Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose
Article. 10.3390/ijms25042112. 2024
Amyloid brain-dedicated PET images can diagnose Alzheimer's pathology with Centiloid Scale.
Gandia-Ferrero MT; (...); Martí-Bonmatí L
Article. 10.1016/j.ejmp.2024.103345. 2024
Arthritis, Pulmonary Cysts and Renal Insufficiency: COPA Syndrome.
Balaguer Cartagena MN, Fonfría Esparcia C, Anguera de Francisco G
Article. 10.1016/j.arbres.2024.04.005. 2024
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
CD34-negative, STAT6-negative, Low-grade, Low-risk Solitary Fibrous Tumor
Monteagudo C; (...); Machado I
Article. 10.1097/PAS.0000000000002087. 2024
ComBat harmonization in different PET imaging scenarios
Gandia-Ferrero, M.; (...); Marti-Bonmati, L.
Meeting Abstract. 2023
Comparison of protocols with respiratory-gated (4D) motion compensation in PET/CT: open-source package for quantification of phantom image quality.
Martinez-Movilla, Andrea; (...); Carles, Montserrat
Article. 10.1186/s40658-022-00509-4. 2022
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
Disseminated toxoplasma infection after hematopoietic stem cell transplantation with myositis and encephalitis.
Asensi Cantó P; (...); Guerreiro M
Article. 10.1111/tid.14067. 2023
Early colorectal cancer diagnosed after endoscopic resection: Conservative treatment is safe in most of the cases. Proposal for a risk-based management.
Sancho-Muriel J; (...); Frasson M
Article. 10.1016/j.cireng.2022.08.018. 2022
Evaluation of Alternative Risk Stratification Systems in a Large Series of Solitary Fibrous Tumors with Molecular Findings and Ki-67 Index Data: Do They Improve Risk Assessment?
Machado, Isidro; (...); Llombart-Bosch, Antonio
Article. 10.3390/ijms24010439. 2022
Exploring the potential of optical genome mapping in soft-tissue and bone tumours
Mayordomo Aranda, E.; (...); Such Taboada, E.
Meeting Abstract. 2024
Extra-meningeal Solitary Fibrous Tumor: an evolving entity with chameleonic morphological diversity, a hallmark molecular alteration and unresolved issues in risk stratification assessment.
Machado, Isidro; (...); Llombart-Bosch, Antonio
Article. 10.14670/HH-18-608. 2023
Extraskeletal myxoid chondrosarcoma: p53 and Ki-67 offer prognostic value for clinical outcome - an immunohistochemical and molecular analysis of 31 cases.
Giner, Francisco; (...); Llombart-Bosch, Antonio
Article. 10.1007/s00428-022-03453-x. 2022
Extra-Skeletal Osteosarcoma of the Prostate After Treated Prostatic Acinar Adenocarcinoma: A Case Report and Review of the Literature.
García CR; (...); Segura FG
Article. 10.1177/10668969241283735. 2024
Free automatic software for quality assurance of computed tomography calibration, edges and radiomics metrics reproducibility.
Saborido-Moral, Juan D.; (...); Carles, Montserrat
Article. 10.1016/j.ejmp.2023.103153. 2023
GALLANT-1: GB1211 galectin-3 (Gal-3) inhibitor plus atezolizumab (atz) for first line treatment in patients (pts) with advanced/metastatic non-small cell lung cancer (NSCLC)
Aparisi Aparisi, F. D. A.; (...); Ghiringhelli, F.
Meeting Abstract. 10.1016/j.annonc.2023.09.2491. 2023
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Immunological Tumor Microenvironment of Solitary Fibrous Tumors-Associating Immune Infiltrate with Variables of Prognostic Significance
Medina-Ceballos, Emilio; (...); Llombart-Bosch, Antonio
Article. 10.3390/cancers16183222. 2024
Intimal Sarcoma with MDM2/CDK4 Amplification and p16 Overexpression: A Review of Histological Features in Primary Tumor and Xenograft, with Immunophenotype and Molecular Profiling.
Giner, Francisco; (...); Llombart-Bosch, Antonio
Article. 10.3390/ijms24087535. 2023
Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.
Pozo-Rosich P; (...); Irimia P
Article. 10.1186/s10194-024-01747-w. 2024
Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.
Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula
Article. 10.3390/antibiotics13080706. 2024
Labyrinthine Bifurcation of the Facial Nerve
Saro-Buendia, Miguel; (...); Carceller, Miguel Armengot
Article. 10.1007/s12070-023-03977-x. 2023
Long-term treatment outcomes of complicated acute diverticulitis in immunocompromised patients.
Sancho-Muriel, Jorge; (...); Flor-Lorente, Blas
Article. 10.1007/s00384-024-04753-1. 2024
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
Novel EVI5::BRAF Gene Fusion in Infantile Fibrosarcoma: A Case Report and Review of Literature
Gonzalez-Lopez, Judith; (...); Giner, Francisco
Article. 10.3390/ijms26031182. 2025
Objective Image Quality Comparison Between Brain-Dedicated PET and PET/CT Scanners.
Gandia-Ferrero MT; (...); Martí-Bonmatí L
Article. 10.1007/s10916-023-01984-7. 2023
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
One step beyond right hemicolectomy with D3 lymphadenectomy: Central ligation of middle colic vessels-A video vignette.
Sancho-Muriel, Jorge; (...); Frasson, Matteo
Letter. 10.1111/codi.70017. 2025
OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT
Flores-Moreno, S.; (...); Gil, A.
Meeting Abstract. 2024
Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.
Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis
Article. 10.3390/ijms26041760. 2025
Posterior Lingual Abscess; Report of Two Cases.
Saro-Buendia, Miguel; (...); Armengot Carceller, Miguel
Case Reports. 10.22037/aaem.v11i1.1860. 2023
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.
Falkenhain-Lopez, D; (...); Ortiz-Romero, P L
Article. 10.1016/j.ad.2022.11.010. 2023
Primary Papillary Colonic Adenocarcinoma With PDGFRA Mutation. A New Morphological Subtype? A Case Report and Review of Literature.
Gonzalez-Lopez, Judith; (...); Giner, Francisco
Article. 10.1177/10668969241228293. 2024
Quantitative evaluation of a non-CT based attenuation correction method for a new dedicated brain PET
Gandia-Ferrero, M.; (...); Marti-Bonmati, L.
Meeting Abstract. 2022
Relationship between neuroimaging and emotion recognition in Mild Cognitive Impairment patients.
Gandia-Ferrero, Maria Teresa; (...); Marti-Bonmati, Luis
Article. 10.1016/j.bbr.2023.114844. 2024
Sequential treatment of High-risk Neuroblastoma combining I-131 MIBG high-dose and Topotecan. First experience
Orrego, N.; (...); Bello-Arques, P.
Meeting Abstract. 2023
Solitary fibrous tumor: Can the new Huang risk stratification system for orbital tumors improve prognostic accuracy in other tumor locations?
Medina-Ceballos, Emilio; (...); Llombart-Bosch, Antonio
Article. 10.1016/j.prp.2024.155143. 2024
State of the art and future perspectives of new radionuclides in Nuclear Medicine.
Rosales, J J; (...); Quincoces, G
Article. 10.1016/j.remnie.2025.500082. 2025
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The Combined Immunohistochemical Expression of GLI1 and BCOR in Synovial Sarcomas for the Identification of Three Risk Groups and Their Prognostic Outcomes: A Study of 52 Patients.
Giner, Francisco; (...); Llombart-Bosch, Antonio
Article. 10.3390/ijms25147615. 2024
The percentage of mesorectal infiltration as a prognostic factor after curative surgery for pT3 rectal cancer.
Sancho-Muriel, Jorge; (...); Frasson, Matteo
Article. 10.1111/codi.16522. 2023
The value of GLI1 and p16 immunohistochemistry in the premolecular screening for GLI1-altered mesenchymal neoplasms.
Machado, Isidro; (...); Llombart-Bosch, Antonio
Article. 10.1007/s00428-023-03687-3. 2023
The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
Badia, Xavier; (...); Valles, Joan-Antoni
Article. 10.1186/s13023-024-03324-5. 2024
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Tumor Microenvironment and Its Clinicopathologic and Prognostic Association in Cutaneous and Noncutaneous Angiosarcomas.
Machado, Isidro; (...); Llombart-Bosch, Antonio
Article. 10.1093/ajcp/aqad003. 2023
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023
Y-90 PET/MR imaging optimization with a Bayesian penalized likelihood reconstruction algorithm.
Calatayud-Jordan, Jose; (...); Torres-Espallardo, Irene
Article. 10.1007/s13246-024-01452-7. 2024