Portal de recerca
Estudio multicéntrico, abierto, de fase I/II de EOS884448 en combinación con el tratamiento estándar y/o terapias experimentales en participantes con tumores sólidos avanzados.
Dades bàsiques
- Protocol:
- TIG-006
- EURDRACT:
- 2021-001329-29
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2023
- Any de finalització:
Objectius del projecte
Objetivo Principal: Parte 1: Determinación de dosis: •Caracterizar la seguridad y tolerabilidad de EOS884448 (EOS-448) en combinación con el tratamiento estándar y/o terapias experimentales y de dostarlimab en combinación con inupadenant HCl en participantes con tumores sólidos avanzados •Establecer la dosis recomendada para la fase 2 (RP2D) de EOS-448 en combinación con el tratamiento estándar y/o terapias experimentales e inupadenant en combinación con dostarlimab en participantes con tumores sólidos avanzados Parte 2: Expansión: •Evaluar la actividad antitumoral (i) de la combinación de EOS-448 y pembrolizumab en cáncer metastásico de pulmón de células no pequeñas en primera línea (1L mNSCLC, partes 2A y 2B); (ii) de la combinación de EOS-448 y dostarlimab en carcinoma metastásico de células escamosas de cabeza y cuello en primera línea (1L mHNSCC, partes 2C y 2D), (iii) de la combinación de EOS-448 con inupadenant HCl en melanoma cutáneo metastásico resistente a anti-PD-(L)1 (parte 2E) Objetivos Secundarios: Secundarios Parte 1:Determinación de la dosis: •Evaluar actividad antitumoral de EOS-448 en combinación con el tratamiento estándar y/o terapias experimentales y de inupadenant en combinación con dostarlimab en participantes con tumores sólidos avanzados •La tasa de respuesta general (ORR) se definirá según RECIST v1.1 Parte 1 y parte 2: •Evaluar la actividad antitumoral según el tiempo de supervivencia en participantes tratados con EOS-448 en combinación con el tratamiento estándar y/o terapias experimentales y de inupadenant en combinación con dostarlimab en participantes con tumores sólidos avanzados •Evaluar (i) la farmacocinética (PK) y la inmunogenicidad de EOS-448 en combinación con el tratamiento estándar y/o terapias experimentales en participantes con tumores sólidos avanzados •Evaluar la farmacocinética (PK) de inupadenant cuando el fármaco (base libre o con sal HCl) se administra en combinacióncon (i)EOS-448,(ii)dostarlimab, o(iii) EOS-448 y dostarlimab
Documents
- No hi ha documents
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
[Translated article] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study.
Segui-Solanes, Carlos; (...); Borras-Blasco, Joaquin
Article. 10.1016/j.farma.2024.08.002. 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
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
Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study.
Passaro, A; (...); Cho, B C
Article. 10.1016/j.annonc.2023.10.117. 2024
Benefits of physical activity self-monitoring in patients with haemophilia: a prospective study with one-year follow-up.
Pérez-Alenda S; (...); Núñez-Cortés R
Article. 10.1111/hae.14988. 2024
CA125: a new biomarker in patients with Fontan circulation (vol 76, pg 112, 2023)
Fuentes, Francisco Buendia; (...); Soriano, Joaquin Rueda
Correction. 10.1016/j.rec.2023.03.018. 2023
Capmatinib vs docetaxel as second- or third-line (2/3L) therapy in patients (pts) with METex14-mutated advanced NSCLC (aNSCLC): The GeoMETry-III trial
Vidal, O. J. Juan; (...); Wolf, J.
Meeting Abstract. 10.1016/j.annonc.2023.09.2424. 2023
CD34-negative, STAT6-negative, Low-grade, Low-risk Solitary Fibrous Tumor
Monteagudo C; (...); Machado I
Article. 10.1097/PAS.0000000000002087. 2024
Correction to: SEOM-GECP Clinical guidelines for diagnosis, treatment and follow-up of small-cell lung cancer (SCLC) (2022).
García-Campelo R; (...); Dómine M
Correction. 10.1007/s12094-023-03290-7. 2023
Cost-effectiveness and cost-utility analysis of haemate-P versus other von willebrand disease treatments in Spain.
Megias-Vericat, Juan E; (...); Yan, Songkai
Article. 10.1080/13696998.2025.2474886. 2025
Characterization of patients with advanced non-small-cell lung cancer (NSCLC) harboring KRASG12C mutation and their associated direct healthcare costs in Spanish routine clinical practice (SILK study)
Aransay, N. Reguart; (...); Vila, A. Lloansi
Meeting Abstract. 10.1016/j.annonc.2023.09.2442. 2023
Chronological and Biological Age as a Response Factor to Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer
Suay, G.; (...); Juan-Vidal, O.
Meeting Abstract. 2024
Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study.
Ahn, Myung-Ju; (...); Sands, Jacob
Article. 10.1200/JCO-24-01544. 2024
Datopotamab Deruxtecan Vs Docetaxel in Patients with Non-Small Cell Lung Cancer: Final Overall Survival from TROPION-Lung01
Sands, J.; (...); Ahn, M-J
Meeting Abstract. 2024
Development and testing of a mobile app for systematic collection of patient-reported outcomes (PROs) in patients with hemophilia.
Megias-Vericat, J E; (...); Poveda Andres, J L
Letter. 10.1016/j.thromres.2024.109122. 2024
Development of a predictive model for early detection of lung cancer: SREAL-eLUNG study
Vidal, O. J. Juan; (...); Martinez, B. Valdivieso
Meeting Abstract. 2023
Disseminated toxoplasma infection after hematopoietic stem cell transplantation with myositis and encephalitis.
Asensi Cantó P; (...); Guerreiro M
Article. 10.1111/tid.14067. 2023
ECONOMIC BURDEN OF ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) PATIENTS HARBORING KRASG12C MUTATION IN SPAIN
Fernandez-Barcelo, C.; (...); Sampietro-Colom, L.
Meeting Abstract. 2023
Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in non-small-cell lung cancer (NSCLC) with c-METexon 14 skipping mutations (METex14).
Brandao, Mariana da Rocha Almeida; (...); Felip, Enriqueta
Meeting Abstract. 2024
European Society of Medical Oncology (ESMO) guidelines for oncogene-addicted metastatic non-small cell lung cancer (NSCLC): a personalized treatment for each patient.
Suay, Guillermo, Aparisi, Francisco, Juan-Vidal, Oscar
Article. 10.21037/cco-23-100. 2024
Expert Consensus on the Management of Adverse Events of Lorlatinib in the Treatment of ALK+ Advanced Non-small Cell Lung Cancer.
Arriola E; (...); Felip E
Article. 10.1007/s40261-024-01379-7. 2024
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
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
First-line (1L) nivolumab (N) plus ipilimumab (I) plus chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4-y clinical update and outcomes by tumor histologic subtype (THS)
Carbone, David Paul; (...); Reck, Martin
Meeting Abstract. 2023
First-line (1L) nivolumab (N) plus ipilimumab (I) plus chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4-y clinical update and outcomes by tumor histologic subtype (THS).
Carbone, David Paul; (...); Reck, Martin
Meeting Abstract. 10.1200/JCO.2023.41.17_suppl.LBA9023. 2023
First-line Nivolumab (N) plus Ipilimumab (I) plus Chemotherapy (C) in Metastatic NSCLC (mNSCLC): CheckMate 9LA 4-Year Clinical Update
Baclin, Firas; (...); Reck, Martin
Meeting Abstract. 2024
Five-year outcomes with first-line (1L) nivolumab plus ipilimumab plus chemotherapy (N plus I plus C) vs C in patients (pts) with metastatic NSCLC (mNSCLC) in CheckMate 9LA.
Reck, Martin; (...); Paz-Ares, Luis G.
Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.8560. 2024
Five-year outcomes with first-line nivolumab plus ipilimumab with 2 cycles of chemotherapy versus 4 cycles of chemotherapy alone in patients with metastatic non-small cell lung cancer in the randomized CheckMate 9LA trial.
Reck M; (...); Paz-Ares LG
Article. 10.1016/j.ejca.2024.114296. 2024
Four-year clinical update and treatment switching-adjusted outcomes with first-line nivolumab plus ipilimumab with chemotherapy for metastatic non-small cell lung cancer in the CheckMate 9LA randomized trial.
Carbone DP; (...); Reck M
Article. 10.1136/jitc-2023-008189. 2024
FURTHER: A global study to evaluate furmonertinib in patients with EGFR mutant NSCLC including uncommon EGFR mutations (FURMO-002)
Le, Xiuning; (...); Wang, Jie
Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.TPS8666. 2024
FURTHER: A Global, Randomized Study of Firmonertinib at Two Dose Levels in TKI-Naive, Advanced NSCLC with EGFR PACC Mutations
Le, X.; (...); Wang, J.
Meeting Abstract. 2024
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
Health-Related Quality of Life (HRQoL) Outcomes with Adagrasib vs Docetaxel in KRASG12C-Mutated Advanced NSCLC in KRYSTAL-12
Felip, E.; (...); Duruisseaux, M.
Meeting Abstract. https://doi.org/10.1016/j.jtho.2024.09.056. 2024
Immune checkpoint inhibitors as first-line treatment for brain metastases in stage IV NSCLC patients without driver mutations
Suay, Guillermo; (...); Lahoz, Agustin
Review. 10.1016/j.canlet.2024.217317. 2024
Immunogenicity of COVID-19 vaccines in lung cancer patients.
Provencio M; (...); Calvo V
Article. 10.1016/j.lungcan.2023.107323. 2023
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
Incidence and Risk Factors for Development of Cardiac Toxicity in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia
Boluda, Blanca; (...); Montesinos, Pau
Article. 10.3390/cancers15082267. 2023
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
KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation
Mok, Tony S. K.; (...); Barlesi, Fabrice
Meeting Abstract. 10.1200/JCO.2024.42.17_suppl.LBA8509. 2024
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
Mental, emotional and social dimensions of quality of life and their relationship with physical and functional status in adults with haemophilia.
Rodríguez MA; (...); Chimeno-Hernández A
Article. 10.1016/j.thromres.2024.109181. 2024
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
Novel Combinations of Immunotherapies or DNA Damage Repair Inhibitors in Platinum-Refractory Extensive-Stage Small-Cell Lung Cancer: The Phase II BALTIC Study.
Reinmuth, Niels; (...); Bondarenko, Igor
Article. 10.1158/1078-0432.CCR-24-0013. 2024
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
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 Trial of Atezolizumab Combined With Carboplatin and Pemetrexed for Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer With Untreated Brain Metastases (Atezo-Brain, GECP17/05).
Nadal E; (...); Bruna J
Article. 10.1200/JCO.22.02561. 2023
Plain language summary: tarlatamab for patients with previously treated small cell lung cancer.
Ahn, Myung-Ju; (...); Paz-Ares, Luis
Article. 10.1080/14796694.2024.2402152. 2024
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
Real-world outcomes of first-line pembrolizumab (Pem) for metastatic non-small cell lung cancer (mNSCLC) with >= 50% expression of programmed cell death-ligand 1 (PD-L1): A multicentre retrospective study
Perea, J.; (...); Gaudens, P. Capdevila
Meeting Abstract. 2023
RET Fusion Testing in Patients With NSCLC: The RETING Study.
Conde, Esther; (...); Lopez-Rios, Fernando
Article. 10.1016/j.jtocrr.2024.100653. 2024
Sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO): Primary results from the phase 3 EVOKE-01 study.
Paz-Ares, Luis G.; (...); Garassino, Marina Chiara
Meeting Abstract. 10.1200/JCO.2024.42.17_suppl.LBA8500. 2024
Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study.
Paz-Ares, Luis G.; (...); Garassino, Marina Chiara
Article. 10.1200/JCO.24.00733. 2024
Sacituzumab Govitecan vs Docetaxel in Patients with mNSCLC Non-responsive to Last Anti-PD-(L)1containing Regimen: EVOKE-01
Garassino, M. C.; (...); Paz-Ares, L. G.
Meeting Abstract. 2024
SEOM-GECP Clinical guidelines for diagnosis, treatment and follow-up of small-cell lung cancer (SCLC) (2022).
Garcia-Campelo, Rosario; (...); Domine, Manuel
Article. 10.1007/s12094-023-03216-3. 2023
Sex Differences in the Efficacy of Immune Checkpoint Inhibitors in Neoadjuvant Therapy of Non-Small Cell Lung Cancer: A Meta-Analysis
Suay, Guillermo; (...); Juan-Vidal, Oscar
Review. 10.3390/cancers15184433. 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
Spatially Preserved Multi-Region Transcriptomic Subtyping and Biomarkers of Chemoimmunotherapy Outcome in Extensive-Stage Small Cell Lung Cancer.
Peressini M; (...); Zugazagoitia J
Article. 10.1158/1078-0432.CCR-24-0104. 2024
Survival outcomes in ALK-positive NSCLC patients (p) treated 1st line brigatinib and impact of the ALK fusion variant
Provencio-Pulla, Mariano; (...); Romero, Atocha
Meeting Abstract. 2023
Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer.
Ahn MJ; (...); Paz-Ares L
Article. 10.1056/NEJMoa2307980. 2023
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 S-REAL study: Spanish real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy.
Gomez Rueda, Ana; (...); Garrido, Pilar
Article. 10.1007/s12094-024-03404-9. 2024
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
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