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A Phase 1b/2, Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacodynamics and Antitumor Activity of GX-I7 in Combination With Pembrolizumab in Subjects With Refractory or Relapsed (R/R) TNBC

Trial Profile

A Phase 1b/2, Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacodynamics and Antitumor Activity of GX-I7 in Combination With Pembrolizumab in Subjects With Refractory or Relapsed (R/R) TNBC

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 30 Jul 2019

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At a glance

  • Drugs Efineptakin alfa (Primary) ; Pembrolizumab (Primary) ; Cyclophosphamide
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms KEYNOTE-899
  • Sponsors Genexine
  • Most Recent Events

    • 26 Apr 2019 According to a Genexine media release, the company has received authorization to proceed from The Korean Ministry of Food and Drug Safety (MFDS) to initiate this Phase 1b/2 study. The clinical trial is currently under recruitment in about ten clinical sites in Korea including Samsung Medical Center.
    • 26 Apr 2019 According to a Genexine media release, first patient has been dosed in the trial.
    • 26 Apr 2019 Status changed from not yet recruiting to recruiting, according to a Genexine media release.
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