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A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DART Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors

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Trial Profile

A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DART Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 14 Aug 2019

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At a glance

  • Drugs INCMGA 0012 (Primary) ; Orlotamab (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions
  • Sponsors MacroGenics

    • Most Recent Events

    • 05 Mar 2019 Planned number of patients changed from 165 to 139.
    • 25 Jan 2019 According to a MacroGenics media release, the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase 1 monotherapy and combination studies of MGD009. Enrollment of new patients in the U.S. has been cleared to proceed with these trials.
    • 25 Jan 2019 Status changed from suspended to recruiting, according to a MacroGenics media release.
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