{"doi":"10.1016/j.ejca.2026.116821","title":"Dendrimer-nanoparticle (DEP) delivery of cabazitaxel (DEP-cabazitaxel): A first-in-human phase 1/2 trial in patients with advanced solid tumours","abstract":null,"journal":"European Journal of Cancer","year":2026,"id":628190,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":627449,"name":"David J. Pinato","orcid":"0000-0002-3529-0103","position":1,"is_corresponding":false},{"id":1210231,"name":"Martin D. Forster","orcid":null,"position":2,"is_corresponding":false},{"id":282242,"name":"Anthony M. Joshua","orcid":"0000-0001-5159-4580","position":3,"is_corresponding":false},{"id":1109139,"name":"James Korolewicz","orcid":"0000-0002-8006-5466","position":4,"is_corresponding":false},{"id":1626328,"name":"Karam Aboud","orcid":"0009-0000-8491-2178","position":5,"is_corresponding":false},{"id":848345,"name":"Cienne Morton","orcid":"0000-0002-1912-2636","position":6,"is_corresponding":false},{"id":334282,"name":"Jia Liu","orcid":"0000-0001-9522-6624","position":7,"is_corresponding":false},{"id":1626329,"name":"Rasha Cosman","orcid":null,"position":8,"is_corresponding":false},{"id":1013786,"name":"Sarah Benafif","orcid":"0000-0003-1407-1697","position":9,"is_corresponding":false},{"id":1626330,"name":"Stephanie R. Edmondson","orcid":"0009-0004-3274-9427","position":10,"is_corresponding":false},{"id":612002,"name":"Jeremy Ra Paull","orcid":"0000-0002-9981-421X","position":11,"is_corresponding":false},{"id":1626331,"name":"Nicola J. Main","orcid":"0009-0009-3756-4495","position":12,"is_corresponding":false},{"id":1626332,"name":"Julia Angeles","orcid":null,"position":13,"is_corresponding":false},{"id":856383,"name":"James Spicer","orcid":"0000-0003-3732-8491","position":14,"is_corresponding":false},{"id":928513,"name":"Robert H. Jones","orcid":"0000-0003-3576-9496","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Dendrimer-nanoparticle (DEP) delivery of cabazitaxel (DEP-cabazitaxel): A first-in-human phase 1/2 trial in patients with advanced solid tumours","abstract":"<h4>Background</h4>This phase 1/2 trial evaluated safety, tolerability, pharmacokinetics, and antitumour activity of DEP-cabazitaxel (CTX-SPL9111), a dendrimer-cabazitaxel nanoparticle, in solid tumours.<h4>Methods</h4>Adult patients received DEP-cabazitaxel once every 3 weeks. The primary phase 1 objective was to establish the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs). Secondary objectives were to assess safety and tolerability, define the recommended phase 2 dose (RP2D), and evaluate pharmacokinetics and preliminary efficacy.<h4>Results</h4>Eighty-nine patients enrolled; most phase 2 patients had metastatic castrate-resistant prostate cancer (mCRPC; n = 25), platinum-resistant ovarian cancer (PROC; n = 22), or esophago-gastric cancer (EGC; n = 15). No DLTs were observed at the MTD and RP2D of 20 mg/m<sup>2</sup> cabazitaxel. Most common treatment-emergent adverse events attributed to DEP-cabazitaxel were fatigue, peripheral neuropathy, nausea, anaemia, neutropenia, diarrhoea, and vomiting. In 75 phase 2 patients, Grade 3/4 neutropenia occurred in 22.7% and febrile neutropenia in 1.3%. In RECIST-evaluable phase 2 patients, the objective response rate (ORR) was 20% (9/45 measurable) and disease control rate (DCR) was 70.6% (36/51). By tumor type, ORRs were 16.7%, 17.6%, 30.0%, and 100% for mCRPC, PROC, EGC, and a thymic cancer patient, respectively. In evaluable phase 2 patients, 90.5% with mCRPC had PSA reductions (52.4% by >50%) and 86.7% had stable or improved bone metastases, and 75% with PROC had reduced CA‑125 or CEA. Median progression-free and overall survival were 3.8 and 9.0 months, respectively.<h4>Conclusion</h4>DEP-cabazitaxel was well tolerated and showed durable antitumour activity across advanced solid tumours, with reduced bone marrow toxicity compared to that reported for conventional cabazitaxel.","is_dataset_classified":null,"base_score":0.0,"endowment":0.0,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"42208277","pmcid":null,"openalex_id":"https://openalex.org/W7162110116","authors":[],"funders":[{"funder_name":"National Institute on Handicapped Research","grant_id":"","title":null},{"funder_name":"Cancer Research UK","grant_id":"","title":null},{"funder_name":"National Institute for Health and Care Research","grant_id":"","title":null},{"funder_name":"NIHR Imperial Biomedical Research Centre","grant_id":"","title":null},{"funder_name":"National Institute for Health Research (NIHR)","grant_id":"","title":null},{"funder_name":"UCLH Biomedical Research Centre","grant_id":"","title":null},{"funder_name":"Imperial Experimental Cancer Medicine Centre","grant_id":"","title":null},{"funder_name":"Université Catholique de Louvain","grant_id":"","title":null}],"total_grants":8,"fwci":0.0,"citation_percentile":0.4630143,"influential_citations":0,"citation_trend":[],"oa_status":"green","license":"cc-by-nc-nd","oa_locations":[{"url":"https://kclpure.kcl.ac.uk/portal/en/publications/ea69d1a4-7434-4d22-9c41-0392f6f013df","host_type":"repository"},{"url":"https://kclpure.kcl.ac.uk/portal/en/publications/ea69d1a4-7434-4d22-9c41-0392f6f013df","host_type":"GREEN"},{"url":"https://kclpure.kcl.ac.uk/portal/en/publications/ea69d1a4-7434-4d22-9c41-0392f6f013df","host_type":"repository"},{"url":"https://api.elsevier.com/content/article/PII:S0959804926006027?httpAccept=text/xml","host_type":"publisher"},{"url":"https://api.elsevier.com/content/article/PII:S0959804926006027?httpAccept=text/plain","host_type":"publisher"},{"url":"https://doi.org/10.1016/j.ejca.2026.116821","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/42208277","host_type":"repository"}],"fields_of_study":["Dendrimers and Hyperbranched Polymers","Nanoparticle-Based Drug Delivery","Cancer Research and Treatment","Medicine","Adult","Aged","Aged, 80 and over","Female","Humans","Male","Middle Aged","Antineoplastic Agents","Dendrimers","Maximum Tolerated Dose","Nanoparticles","Neoplasms","Progression-Free Survival","Taxoids"],"mesh_terms":["Progression-Free Survival","Adult","Aged","Aged, 80 and over","Antineoplastic Agents","Female","Humans","Male","Middle Aged","Neoplasms","Maximum Tolerated Dose","Taxoids","Dendrimers","Nanoparticles"],"keywords":["Cabazitaxel","Maximum tolerated dose","Phase (matter)","Phases of clinical research","Clinical trial","Ovarian cancer","prostate cancer","Dendrimer Nanoparticle","Esophago-gastric Cancer"],"sdg_mappings":[],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-05T11:42:35.846694Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}