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A Phase I, Multi-center, Open-label, Single-arm, Dose-escalation and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activities of FCN-411 Monotherapy in Advanced Non-small Cell Lung Cancer

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Trial Profile

A Phase I, Multi-center, Open-label, Single-arm, Dose-escalation and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activities of FCN-411 Monotherapy in Advanced Non-small Cell Lung Cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 07 Jul 2022

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At a glance

  • Drugs FCN-411 (Primary)
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Ahon Pharmaceutical

    • Most Recent Events

    • 01 Apr 2022 Results (at cut-off date February 1 2021, n=77) evaluating safety, tolerability, antitumor activity, and pharmacokinetics of FCN-411, published in the Lung Cancer
    • 14 Jul 2020 Planned number of patients changed from 66 to 90.
    • 13 Jul 2020 Planned End Date changed from 20 Dec 2019 to 20 Dec 2021.

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