Portal de investigación
Ensayo de fase I/II multicéntrico y abierto que evalúa la seguridad, tolerabilidad y eficacia de MORAb-202, un conjugado anticuerpo-fármaco (ADC) dirigido a receptores alfa de folato (FRα), en pacientes con determinados tipos de tumores.
Datos básicos
- Código:
- MORAb-202-G000-201
- Protocolo:
- MORAb-202-G000-201
- EUDRACT:
- 2019-003600-12
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2023
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: Objetivos principales Objetivo principal de la parte de aumento escalonado de la dosis: • Evaluar la seguridad y la tolerabilidad, y determinar la dosis recomendada para la fase II (DRF2) de MORAb-202 en pacientes con determinados tipos de tumores (cáncer de ovario [CO], cáncer de endometrio [CE], carcinoma pulmonar no microcítico [CPNM], cáncer de mama triple negativo [CMTN]). Objetivos principales de la parte de confirmación de la dosis: • Evaluar más a fondo la seguridad y tolerabilidad de MORAb-202. • Evaluar la eficacia preliminar medida por la tasa de respuesta objetiva (TRO) de MORAb-202 en pacientes con CO y CE con el uso de dosis específicas. Objetivos Secundarios: Objetivos secundarios: • Evaluar la duración de la respuesta (DR), la tasa de control de la enfermedad (TCE) y la tasa de beneficio clínico (TBC). • Evaluar la supervivencia sin progresión (SSP) y la supervivencia global (SG). • Determinar los perfiles farmacocinéticos (FC) de MORAb-202, anticuerpos totales y eribulina liberada en suero o plasma. • Evaluar la relación entre los niveles de expresión del receptor alfa de folato (FRa) y las mediciones de resultados clínicos para respaldar la identificación de un valor de corte apropiado para FRa.
Documentos
- No hay documentos
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[[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 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
A Smart Digital Health Platform to Enable Monitoring of Quality of Life and Frailty in Older Patients with Cancer: A Mixed-Methods, Feasibility Study Protocol.
Papachristou, Nikolaos; (...); Bamidis, Panagiotis D.
Article. 10.1016/j.soncn.2023.151437. 2023
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
Analysis of Tumor Microenvironment Changes after Neoadjuvant Chemotherapy with or without Bevacizumab in Advanced Ovarian Cancer (GEICO-89T/MINOVA Study).
Tavira B; (...); González-Martín A
Article. 10.1158/1078-0432.CCR-23-0771. 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
Atezolizumab (atezo) combined with platinum-based chemotherapy (CT) and maintenance niraparib for recurrent ovarian cancer (rOC) with a platinum-free interval (TFIp) >6 months: Primary analysis of the double-blind placebo (pbo)controlled ENGOT-Ov41/GEICO 69-O/ANITA phase III trial
Martin, A. Gonzalez; (...); Selle, F.
Meeting Abstract. 10.1016/j.annonc.2023.10.031. 2023
Atezolizumab Combined With Platinum and Maintenance Niraparib for Recurrent Ovarian Cancer With a Platinum-Free Interval >6 Months: ENGOT-OV41/GEICO 69-O/ANITA Phase III Trial.
Gonzalez-Martin, Antonio; (...); Selle, Frederic
Article. 10.1200/JCO.24.00668. 2024
Cavernous Sinus Thrombosis Secondary to Streptococcus Constellatus Pharynges
Jaramillo-Angel, Natalia; (...); Carceller, Miguel Armengot
Article. 10.1007/s12070-024-04511-3. 2024
Clinical and molecular signature of survival and resistance to olaparib plus pegylated liposomal doxorubicin in platinum-resistant ovarian cancer: a stratified analysis from the phase II clinical trial ROLANDO, GEICO-1601.
Perez-Fidalgo, Jose Alejandro; (...); Gonzalez-Martin, Antonio
Article. 10.1136/ijgc-2022-004028. 2023
Clinical experience of whole body and tumour dosimetry of 131-I-mIBG treatment for pediatric patients
Espallardo, I. Torres; (...); Prado-Wohlwend, S.
Meeting Abstract. 2023
ComBat harmonization in different PET imaging scenarios
Gandia-Ferrero, M.; (...); Marti-Bonmati, L.
Meeting Abstract. 2023
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
CXCR4: From Signaling to Clinical Applications in Neuroendocrine Neoplasms.
Sanchis-Pascual, David; (...); Merino-Torres, Juan Francisco
Article. 10.3390/cancers16101799. 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
Cyclin E cytoplasmatic isoform to predict outcome and benefit to capecitabine treatment in patients with HR+/HER2-metastatic breast cancer from the GEICAM/2013-02 PEARL study
Guerrero, Angel; (...); Martin, Miguel
Meeting Abstract. 2023
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
Effect of aging on the human myometrium at single-cell resolution.
Punzon-Jimenez, Paula; (...); Mas, Aymara
Article. 10.1038/s41467-024-45143-z. 2024
Elevation of serum neurofilament light-chain levels disclose possible occult progressive multifocal leukoencephalopathy and immune reconstitution syndrome in a patient receiving ozanimod: a case report.
Quintanilla-Bordás C; (...); Pérez-Miralles FC
Case Reports. 10.3389/fimmu.2024.1465678. 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
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
Hypertension as predictive factor for bevacizumab-containing first-line therapy in metastatic breast and colorectal cancer in BRECOL (GEICAM/2011-04) study.
Rodríguez-Lescure Á; (...); de la Haba-Rodriguez J
Article. 10.1007/s12094-024-03411-w. 2024
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
Long-term outcomes of high-risk HR-positive and HER2-negative early breast cancer patients from GEICAM adjuvant studies and El Alamo IV registry.
Martin, Miguel; (...); Aguiar-Bujanda, David
Article. 10.1007/s10549-023-07002-1. 2023
Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study.
Kristeleit, Rebecca; (...); Subbiah, Vivek
Article. 10.1007/s10637-023-01383-2. 2023
Management of iodine contrast induced salivary gland swelling (sialadenitis): experiences from an observational study.
Saro-Buendía M; (...); Armengot Carceller M
Article. 10.1080/00016489.2022.2162121. 2023
Methylation and expression profiling for Sex CordStromal Tumors of the ovary subtype characterization
Roca, Carla; (...); Rivera, Barbara
Meeting Abstract. 2024
Molecular characterization of pregnancy-associated breast cancer and insights on timing from GEICAM-EMBARCAM study.
Pena-Enriquez, Regina; (...); de la Haba-Rodriguez, Juan
Article. 10.1038/s41523-025-00718-x. 2025
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
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
Open-label phase II clinical trial of ketoconazole as CYP17 inhibitor in metastatic or advanced non-resectable granulosa cell ovarian tumors: the GREKO (GRanulosa Et KetOconazole) trial, GETHI 2011-03.
Garcia-Donas, Jesus; (...); Grande, Enrique
Article. 10.1007/s12094-023-03085-w. 2023
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
Phase II clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016-01).
García-Donas J; (...); Navarro P
Article. 10.1016/j.ygyno.2024.10.019. 2024
Plasma mutational burden in PIK3CA and TP53 independently predicts early progression in patients with HR+/HER2-metastatic breast cancer (MBC) enrolled in the GEICAM/2014-12 FLIPPER trial
Gustavo, Federico; (...); Albanell, Joan
Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.1029. 2024
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
Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial.
Tibau, Ariadna; (...); Albanell, Joan
Article. 10.1177/17588359221148921. 2023
Real-world safety and effectiveness of maintenance niraparib for platinum-sensitive recurrent ovarian cancer: A GEICO retrospective observational study within the Spanish expanded-access programme.
Cueva, Juan F.; (...); Gonzalez-Martin, Antonio
Article. 10.1016/j.ejca.2022.12.023. 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
Role of the receptor for advanced glycation end products (RAGE) in blood as a potential biomarker for progression to olaparib: A post hoc analysis of patients with platinum-resistant ovarian cancer (PROC) treated in the ROLANDO-GEICO 1601 trial
Perez-Fidalgo, Jose Alejandro; (...); Gonzalez-Martin, Antonio
Meeting Abstract. 2024
Rucaparib for PARP inhibitor-pretreated ovarian cancer: A GEICO retrospective subgroup analysis from the Spanish Rucaparib Access Program.
Yubero, Alfonso; (...); Gonzalez-Martin, Antonio
Case Reports. 10.1016/j.gore.2023.101211. 2023
Same-day comparative protocol PET/CT-PET/MRI [68Ga]Ga-DOTA-TOC in paragangliomas and pheochromocytomas: an approach to personalized medicine.
Prado-Wohlwend, Stefan; (...); Merino-Torres, Juan Francisco
Article. 10.1186/s40644-023-00521-6. 2023
Sequential treatment of High-risk Neuroblastoma combining I-131 MIBG high-dose and Topotecan. First experience
Orrego, N.; (...); Bello-Arques, P.
Meeting Abstract. 2023
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 Prognostic Significance of Tumor-Infiltrating Lymphocytes, PD-L1, BRCA Mutation Status and Tumor Mutational Burden in Early-Stage High-Grade Serous Ovarian Carcinoma-A Study by the Spanish Group for Ovarian Cancer Research (GEICO).
Pizarro, David; (...); Palacios, Jose
Article. 10.3390/ijms241311183. 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
Use of liquid biomarker thymidine kinase activity (TKa) to predict outcome and progression in patients with metastatic breast cancer (MBC) in the GEICAM/2014-12 FLIPPER trial
Albanell, Joan; (...); Rojo Todo, Federico Gustavo
Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.1028. 2024
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