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A two-stage phase I\/II trial was designed to evaluate the combination. The first (dose escalation) stage of the trial assessed two schedules, lurbinectedin on Day (D)1 plus irinotecan on D1,D8 or D1 every three weeks in 83 patients with relapsed advanced solid tumors. Two recommended doses (RDs) were defined for lurbinectedin on D1 plus irinotecan on D1,D8: lurbinectedin 2.0\u00a0mg\/m<jats:sup>2<\/jats:sup> plus irinotecan 75\u00a0mg\/m<jats:sup>2<\/jats:sup>, and lurbinectedin 3.0\u00a0mg\/m<jats:sup>2<\/jats:sup> plus irinotecan 40\u00a0mg\/m<jats:sup>2<\/jats:sup>, both with primary growth factor prophylaxis. No RD was defined for lurbinectedin on D1 plus irinotecan on D1. Lurbinectedin on D1 plus irinotecan on D1,D8 q3wk showed a manageable safety profile at the RDs, with most common toxicities being myelosuppression, fatigue and gastrointestinal disorders. No toxic deaths occurred. Thirteen confirmed partial responses and 24 disease stabilizations\u2009\u2265\u20094\u00a0months were found at all dose levels, including the RDs. Compared to other tumor types, antitumor activity was higher in small cell lung cancer (SCLC), soft tissue sarcoma (synovial), endometrial carcinoma, glioblastoma and pancreatic adenocarcinoma. No major pharmacokinetic interaction was found between lurbinectedin and irinotecan. The second (expansion) stage of the trial is evaluating the RD of lurbinectedin 2.0 mg\/m<jats:sup>2<\/jats:sup> plus irinotecan 75 mg\/m<jats:sup>2<\/jats:sup> with primary growth factor prophylaxis in selected advanced solid tumors. An ongoing phase III trial is also evaluating the combination in second-line SCLC after prior platinum-containing chemotherapy. Trial registration number: NCT02611024 (Nov 20, 2015).\n<\/jats:p>","DOI":"10.1007\/s10637-025-01583-y","type":"journal-article","created":{"date-parts":[[2025,9,17]],"date-time":"2025-09-17T23:19:28Z","timestamp":1758151168000},"page":"955-967","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Phase I results on the efficacy, safety and pharmacokinetics of lurbinectedin and irinotecan in advanced solid tumors"],"prefix":"10.1007","volume":"43","author":[{"given":"Alejandro","family":"Falc\u00f3n","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Santiago","family":"Ponce","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory M.","family":"Cote","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Gil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica J.","family":"Lin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Bockorny","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Mart\u00ednez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Kahatt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Martinez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo","family":"Zubiaur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariano","family":"Siguero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Cullell-Young","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Jim\u00e9nez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jon","family":"Zugazagoitia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis","family":"Paz-Ares","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,9,18]]},"reference":[{"issue":"16","key":"1583_CR1","doi-asserted-by":"publisher","first-page":"2545","DOI":"10.1021\/ol0062502","volume":"2","author":"C Cuevas","year":"2000","unstructured":"Cuevas C, Perez M, Martin MJ, Chicharro JL, Fernandez-Rivas C, Flores M, Francesch A, Gallego P, Zarzuelo M, De La Calle F, Garcia J, Polanco C, Rodriguez I, Manzanares I (2000) Synthesis of ecteinascidin ET-743 and phthalascidin Pt-650 from cyanosafracin B. 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No individual patient data are included in this article that could be used to identify any individual.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"A. Falc\u00f3n reports advisory role for Roche, Pfizer, Menarini, AstraZeneca, and MSD; honoraria from Roche, Pfizer, Novartis, Lilly, Menarini, AstraZeneca, MSD, Daiichi, Gilead, Dr. Reddy, and Gr\u00fcnenthal; and travel accommodations from Novartis, Daiichi, Gilead, and Roche. G.M. Cote reports honoraria from Gilead, and BioAtla; consultant role for Chordoma Foundation, and Sonata Therapeutics; Scientific Advisory Board position for Ikena Oncology, C4 Therapeutics, and Daiichi Sankyo, Inc; Institutional research funding to MGH for the conduct of clinical trials from Servier Pharmaceuticals, Pharma Mar, MacroGenics, Eisai, Merck KGaA\/EMD Serono Research and Development Institute, Repare Therapeutics, Foghorn Therapeutics, Jazz Pharmaceuticals, RAIN Oncology, BioAtla, Inhibrx, Ikena Oncology, C4 Therapeutics, Kronos, Bavarian Nordic, and Pyxis; and travel accommodations from Pharma Mar. J.J. Lin reports consulting or advising fees for Genentech, C4 Therapeutics, Blueprint Medicines, Nuvalent, Bayer, Elevation Oncology, Novartis, Mirati Therapeutics, AnHeart Therapeutics, Takeda, CLaiM Therapeutics, Ellipses, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Yuhan, Merus, Regeneron, Pfizer, Roche, Gilead, Janssen, Nuvation Bio, Eli Lilly, AstraZeneca, Gilead, and Turning Point Therapeutics; institutional research funding from Hengrui Therapeutics, Turning Point Therapeutics, Neon Therapeutics, Relay Therapeutics, Bayer, Elevation Oncology, Roche, Linnaeus Therapeutics, Nuvalent, and Novartis; and travel support from Pfizer, Merus, Takeda, and Bristol Myers Squibb. B. Bockorny reports Research Funding from Agenus Inc and NanoView Bioscience; travel expenses from Erytech Pharma; Advisory Board and Consulting from SpringWorks, Blueprint Medicines, BioLine Rx, Boxer and Enlivex; and institutional research funding to BIDMC for the conduct of clinical trials from Gilead, Pfizer, Novartis, Amgen, Bristol Myers Squibb, Incyte, Eli Lily, Relay, Scholar Rock, OncoMatryx, Pharma Mar, MacroGenics, BioLineRx, AbGenomics, Chugai, and Sapience. J. Martinez reports speakers\u2019 or travel honoraria from MSD, Bristol-Myers and Merck. C. Kahatt and P. Zubiaur are employees and stock owners of Pharma Mar. S. Martinez, M. Siguero, M. Cullell-Young and J. Jim\u00e9nez are employees of Pharma Mar. J. Zugazagoitia reports speakers\u2019, advisory or travel honoraria from Boehringer Ingelheim, Janssen, Pierre Fabre, Takeda, Sanofi, BMS, AstraZeneca, MSD, Roche, Pfizer, Novartis, and NanoString; and research support\/grants from AstraZeneca, Roche, and BMS. L. Paz-Ares reports co-founder position and member of board of directors with Altum Sequencing, and Stab therapeutics; consulting fees or advisory role for Abbvie, Amgen, AstraZeneca, Bayer, Beigene, Biontech, Bristol-Myers-Squibb, Boehringer-Ingelheim, Daiichi-Sankyo, GlaxoSmithKline, Gilead, Johnson & Johnson, Lilly, MSD, Merck-Serono, Mirati, Novartis, Pharma Mar, Pfizer, Regeneron, Roche, Sanofi, and Takeda; speakers\u2019bureau for MSD Oncology, BMS, Roche\/Genentech, Pfizer, Lilly, AstraZeneca, and Merck Serono; and institutional research funding from BMS, AstraZeneca, Pharma Mar, MSD, and Pfizer during the conduct of the study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}