RecruitingPhase 1NCT06812104

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

A Phase I, Multicenter, Non-controlled, Open-label, Non-randomized, Dose-escalation Study of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.

Sponsor

Kyowa Kirin Co., Ltd.

Enrollment

156 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory AML and Other Hematologic Malignancies

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called KK2845 for patients with acute myeloid leukemia (AML) — a fast-growing cancer of the blood and bone marrow — that has relapsed (come back after treatment) or is refractory (stopped responding to treatment). **You may be eligible if...** - You are 18 or older - You have a confirmed AML diagnosis according to current WHO classification - Your AML has relapsed after achieving remission, or has not responded to at least one round of standard intensive chemotherapy - You are well enough to participate in a clinical trial **You may NOT be eligible if...** - You have not yet tried standard AML treatment - You have severe organ dysfunction (heart, liver, or kidneys) - You are pregnant or breastfeeding - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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