NCT06812104

Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase I, Multicenter, Uncontrolled, Open-label, Non-randomized, Dose-escalation Study of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Relapsed or Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-10-10
• Primary completion: 2026-12-31
• Completion: 2028-04-30
• First posted: 2025-02-06
• Last updated: 2025-11-18

Locations

10 sites across 1 country: Japan