Phase 12 Study to Test Safety and Effectiveness of KK2430 for Blood Cancers

What this Trial Is About

Researchers are evaluating KK2430, an experimental intravenous drug, as a potential treatment for people with Hematologic Neoplasms. This Phase 12 study aims to understand whether KK2430 is safe, how the body processes it, and whether it shows any effects in treating this condition. KK2430 has not been previously approved by health authorities, and this study marks its first use in humans. Participants will receive KK2430 through intravenous administration, with some possibly receiving a placebo as part of the study design. The study is conducted in a sequential manner, focusing on safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy. The study includes a treatment period lasting an average of three months, during which various assessments will be made. Throughout the study, participants will undergo multiple evaluations including dose level toxicity checks 28 days after the first dose and monitoring of adverse events for about 1.5 years. Other assessments during treatment include pregnancy tests, ECG measurements of QT and QRS intervals, and vital sign monitoring. Participants will be followed from screening through study completion to collect safety and effectiveness data, with the total study period lasting until around October 2027.

A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms