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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

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

Suspended
Phase of Trial: Phase I

Latest Information Update: 28 Dec 2018

At a glance

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

    • 07 Dec 2018 Status changed from recruiting to suspended.
    • 07 Dec 2018 According to a MacroGenics media release, the company announces partial clinical hold on its monotherapy study of MGD009 and a combination study of MGD009 and MGA012. Under this partial hold, no new patients will be recuited in either study until the partial hold is lifted by the FDA. This partial hold was initiated following MacroGenics' reporting of hepatic adverse events on the MGD009 monotherapy trial to the FDA.
    • 05 Jun 2018 Trial design presented at the 54th Annual Meeting of the American Society of Clinical Oncology.
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