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Phase 1/2, First-in-Human, Dose-Escalation Study of X-396 (Ensartinib) in Patients With Advanced Solid Tumors and Expansion Phase in Patients With ALK-positive Non-Small Cell Lung Cancer

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Trial Profile

Phase 1/2, First-in-Human, Dose-Escalation Study of X-396 (Ensartinib) in Patients With Advanced Solid Tumors and Expansion Phase in Patients With ALK-positive Non-Small Cell Lung Cancer

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 15 Feb 2024

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At a glance

  • Drugs Ensartinib (Primary)
  • Indications Brain metastases; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Acronyms eXalt2; Xalt2
  • Sponsors Xcovery Holdings

    • Most Recent Events

    • 13 Sep 2022 Results (n=482) of a Pop PK model development analysis from four clinical trials: BTP-28311, X396-CLI-101, X396-CLI-301, and BTP-42322 presented at the 47th European Society for Medical Oncology Congress
    • 30 Oct 2020 Status changed from active, no longer recruiting to completed.
    • 29 Oct 2019 Results presented in a Vanderbilt-Ingram Cancer Center Media Release.

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