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- W3149930894 abstract "Up-regulation of AXL tyrosine kinase expression is observed various tumor types including EGFR-mutant (EGFRm) NSCLC with progressive disease on EGFR tyrosine kinase inhibitors (TKIs), especially in a T790M negative population. Xenograft studies have demonstrated that combined inhibition of AXL and EGFR can overcome and delay the onset of resistance. Phase 1 studies of DS-1205c, which is a novel, orally administered, highly selective small molecule inhibitor of AXL, in combination with EGFR TKIs are being conducted in patients with EGFRm NSCLC. An ongoing multicenter, open-label, Phase 1 study of DS-1205c in combination with osimertinib in metastatic or unresectable EGFRm NSCLC is being conducted in Taiwan. Eligible subjects must either have evidence of radiological disease progression during treatment with erlotinib, gefitinib, or afatinib without the T790M resistance mutation, or must experience disease progression during osimertinib treatment and no risk factors for QTc prolongation. Subjects initially receive DS-1205c only twice daily during a run-in period of one week, followed by continuous combination treatment with DS-1205c twice daily and osimertinib 80 mg daily (21days/cycle) until disease progression or meet other discontinuation criteria. Escalation of DS-1205c dosing is guided by the modified Continuous Reassessment Method using a Bayesian logistic regression model following the escalation with overdose control principle. Primary and secondary endpoints include safety, pharmacokinetics, and preliminary efficacy. Exploratory biomarker analyses include assessment of tumor AXL expression through immunohistochemistry and hematological biomarkers. Dose Escalation in Cohort 1 (200 mg BID; n=6), and in Cohort 2 (400 mg BID; n=3) has been completed as of Dec 11, 2019. Two dose limiting toxicities (DLT) were observed in one subject in Cohort 1 (Grade 3 pneumonia and Grade 3 increased serum alanine aminotransferase [NCI-CTCAE v.5.0], which led study drug interruption to meet the criteria of DLT for low compliance rate). There were no serious adverse events directly related to DS-1205c. Preliminary analysis of efficacy data reveals that three patients had stable disease beyond 100 days (RECIST v.1.1). Dose escalation is ongoing and updated clinical and biomarker data will be presented." @default.
- W3149930894 created "2021-04-13" @default.
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- W3149930894 date "2021-03-01" @default.
- W3149930894 modified "2023-09-27" @default.
- W3149930894 title "P86.01 Phase 1 Study of the AXL Inhibitor DS-1205 in Combination With Osimertinib in Subjects With Metastatic or Unresectable EGFR-Mutant NSCLC" @default.
- W3149930894 doi "https://doi.org/10.1016/j.jtho.2021.01.1230" @default.
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