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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorMartín Liberal, Juan Jesús
dc.contributor.authorHollebecque, Antoine
dc.contributor.authorAftimos, Philippe
dc.contributor.authorJungels, Christiane
dc.contributor.authorMartin-Romano, Patricia
dc.contributor.authorRodon Ahnert, Jordi
dc.date.accessioned2021-11-11T10:02:38Z
dc.date.available2021-11-11T10:02:38Z
dc.date.issued2020-10
dc.identifier.citationMartin-Liberal J, Hollebecque A, Aftimos P, Jungels C, Martin-Romano P, Rodon J, et al. First-in-human, dose-escalation, phase 1 study of anti-angiopoietin-2 LY3127804 as monotherapy and in combination with ramucirumab in patients with advanced solid tumours. Br J Cancer. 2020 Oct;123:1235–43.
dc.identifier.issn1532-1827
dc.identifier.urihttp://hdl.handle.net/11351/6529
dc.descriptionDrug development
dc.description.abstractBackground This is the first-in-human study of novel anti-angiopoietin-2 (Ang-2) monoclonal antibody LY3127804 as monotherapy and in combination with ramucirumab in advanced solid tumours. Methods Patients received intravenous LY3127804 monotherapy (4, 8, 12, 16, 20 and 27 mg/kg) in part A; LY3127804 (8, 12, 16, 20 and 27 mg/kg) with 8 mg/kg ramucirumab in part B; and LY3127804 (20 mg/kg) with 12 mg/kg ramucirumab in part C. Treatments were administered every 2 weeks (Q2W) during 28-day cycles. Dose-escalation was based on cycle 1 dose-limiting toxicities (DLTs). Results Sixty-two patients were treated in part A (n = 20), part B (n = 35) and part C (n = 7). Constipation, diarrhoea and fatigue were the most common treatment-emergent adverse events (TEAEs) in part A; hypertension and peripheral oedema were the most frequent TEAE in parts B and C. No DLT was observed and maximum tolerated dose for LY3127804 was not reached. Four patients achieved partial response with combination therapy (clear cell endometrial carcinoma, cervix squamous cell carcinoma, carcinoma of unknown primary and gastroesophageal junction carcinoma), 29 achieved stable disease, and 24 had progressive disease. Conclusions LY3127804 monotherapy and its combination with ramucirumab are well tolerated. LY3127804 20 mg/kg was the recommended Phase 2 dose.
dc.language.isoeng
dc.publisherSpringer Nature
dc.relation.ispartofseriesBritish Journal of Cancer;123
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScientia
dc.subjectCàncer - Quimioteràpia
dc.subjectQuimioteràpia combinada
dc.subject.meshNeoplasms
dc.subject.mesh/drug therapy
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.mesh/therapeutic use
dc.titleFirst-in-human, dose-escalation, phase 1 study of anti-angiopoietin-2 LY3127804 as monotherapy and in combination with ramucirumab in patients with advanced solid tumours
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1038/s41416-020-1011-7
dc.subject.decsneoplasias
dc.subject.decs/farmacoterapia
dc.subject.decsprotocolos de quimioterapia antineoplásica combinada
dc.subject.decs/uso terapéutico
dc.relation.publishversionhttps://doi.org/10.1038/s41416-020-1011-7
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Martin-Liberal J] Department of Medical Oncology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Department of Medical Oncology, Catalan Institute of Oncology (ICO), Barcelona, Spain. [Hollebecque A, Martin-Romano P] Department of Adult Medicine, Gustave Roussy, Paris, France. [Aftimos P, Jungels C] Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. [Rodon J] Department of Medical Oncology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
dc.identifier.pmid32741971
dc.identifier.wos000554842400005
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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