Phase I Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.

This is the first in human study of KK2845. This clinical trial consists of Part 1 (Dose Escalation) and Part 2 (Backfill). For patients with relapsed or refractory acute myeloid leukemia (AML) and other Hematologic Malignancies, in Part 1, the tolerability of KK2845 will be evaluated to determine the maximum tolerated dose (MTD). In Part 2, additional data will be collected by administering KK2845 at dose levels for which tolerability has been confirmed.

Trial Details

NCT ID
NCT06812104
Phase
PHASE1
Sponsor
Kyowa Kirin Co., Ltd.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • KK2845_1
  • KK2845_2
  • KK2845_3
  • KK2845_4
  • KK2845_5
  • KK2845_6
Locations (sample)
  • Kamogawa, Chiba, Japan|35.0969,140.1003
  • Yoshida, Fukui, Japan
  • Kurume, Fukuoka, Japan|33.31667,130.51667
  • Sapporo, Hokkaido, Japan|43.06667,141.35
  • Hirakata, Osaka, Japan|34.81352,135.64914

Key Eligibility Criteria

  • 【Patients with Relapsed or Refractory Acute Myeloid Leukemia】
  • Patients with a confirmed diagnosis of AML according to the WHO classification (2022 edition)by pathological examination at the performing institut…
  • Patients who meet the following definition of relapsed or refractory.
  • Relapse: Patients with any of the following relapse findings after achieving CR, CRh, or CRi.

For full eligibility, visit ClinicalTrials.gov.

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