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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06812104 on ClinicalTrials.gov