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Phase 2a/b study of KVA12123 in mutated NPM1 r/r acute myeloid leukemia patients

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Trial Profile

Phase 2a/b study of KVA12123 in mutated NPM1 r/r acute myeloid leukemia patients

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 26 Feb 2026

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At a glance

  • Drugs KVA 12123 (Primary) ; Menin inhibitors (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use

Most Recent Events

  • 17 Feb 2026 According to TuHURA Biosciences media release, the Company plans on initiating a Phase 2 study in menin inhibitor naive patients with mutNPM1 r/r AML utilizing a Simon 2 stage design. Pending completion of FDA review and clearance, the Company currently targets initiating the Phase 2 study in early Q2 2026 with preliminary Stage 1 results in Q3 2026.
  • 17 Feb 2026 According to TuHURA Biosciences media release, company announced that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administrations (FDA) Division of Hematologic Malignancies for the study of TBS-2025 for the treatment of mutNPM1 relapsed/refractory (r/r) Acute Myeloid Leukemia (AML) in combination with a menin inhibitor.
  • 11 Dec 2025 According to TuHURA Biosciences media release, a mini KOL symposium held on December 5, 2025, prior to the ASH meeting, provided valuable scientific rational for targeting VISTA in AML and recommendations on our Phase 2 clinical trial plans for TBS-2025, in AML.

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