Phase I Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.
NCT06812104 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2026-07-01
Summary
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.
Conditions
- Relapsed or Refractory AML and Other Hematologic Malignancies
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).
- DRUG
-
KK2845_7
KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).
- DRUG
-
KK2845_8
KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).
- DRUG
-
KK2845_alternative_1
KK2845 will be administered at several dose levels to collect additional data.
- DRUG
-
KK2845_alternative_2
KK2845 will be administered at several dose levels to collect additional data.
Sponsors & Collaborators
- 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
- 2031-11-30
- Completion
- 2031-11-30
Countries
- Japan
Study Locations
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