Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT06812104 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-11-18
Summary
This is the first in human study of KK2845. This trial consists of Part 1 (Dose escalation) and Part 2 (Backfill). In Part 1, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2845 in patients with relapsed or refractory acute myeloid leukemia. Part 2 will collect additional data at tolerated doses of KK2845.
Conditions
Interventions
- DRUG
-
KK2845_1
KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).
- DRUG
-
KK2845_2
KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).
- DRUG
-
KK2845_3
KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).
- DRUG
-
KK2845_4
KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).
- DRUG
-
KK2845_5
KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).
- DRUG
-
KK2845_6
KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).
Sponsors & Collaborators
-
Kyowa Kirin Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kyowa Kirin Co., Ltd. · Kyowa Kirin Co., Ltd.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-10
- Primary Completion
- 2026-12-31
- Completion
- 2028-04-30
Countries
- Japan
Study Locations
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