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

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Enrollment target: 72 to 156v4 Show 8 more changesShow less
    • Primary completion date: Dec 31, 2026 to Nov 30, 2031
    • Study sites: 10 to 17
    • Study completion date: Apr 30, 2028 to Nov 30, 2031
    • Interventions: KK2845_1 (Drug), KK2845_2 (Drug), KK2845_3 (Drug), KK2845_4 (Drug), KK2845_5 (Drug), KK2845_6 (Drug) to KK2845_1 (Drug), KK2845_2 (Drug), KK2845_3 (Drug), KK2845_4 (Drug), KK2845_5 (Drug), KK2845_6 (Drug), KK2845_7 (Drug), KK2845_8 (Drug)…
    • Eligibility criteria shortened, about 95 words
    • Secondary endpoints: details revised at 2 of 8 entries
    • Study title expanded, about 6 words
    • Study arms: 6 to 16
  2. Enrollment target: 48 to 72v3 Show 5 more changesShow less
    • Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study sites: 1 to 10
    • Interventions: KK2845_1 (Drug), KK2845_2 (Drug), KK2845_3 (Drug), KK2845_4 (Drug) to KK2845_1 (Drug), KK2845_2 (Drug), KK2845_3 (Drug), KK2845_4 (Drug), KK2845_5 (Drug), KK2845_6 (Drug)
    • Eligibility criteria expanded, about 127 words
    • Study arms: 4 to 6
  3. Study title shortened, about 2 wordsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT06812104
Lead Sponsor Kyowa Kirin Co., Ltd.
Conditions
(from sponsor)		 Relapsed or Refractory AML and Other Hematologic Malignancies
Related terms Leukemia, Myeloid, Acute, Recurrence
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov