Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tuspetinib (HM43239) in Patients with Relapsed or Refractory Acute Myeloid Leukemia

The primary objective of the APTIVATE Clinical Trial is to evaluate the **safety**, **tolerability**, **pharmacokinetics**, and **pharmacodynamics** of Tuspetinib (HM43239) in patients with **relapsed or refractory acute myeloid leukemia (AML)**. This study is clinically relevant as it aims to assess the potential of Tuspetinib to provide a therapeutic option for patients with AML who have not responded to standard treatments or have experienced a recurrence of the disease. Understanding the safety profile and pharmacological effects of Tuspetinib is crucial for determining its viability as a treatment option in this patient population.

The clinical trial involves a total of **115 participants** diagnosed with **Relapsed or Refractory Acute Myeloid Leukemia (AML)**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria have not been disclosed. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the general health status of the participants beyond their diagnosis of AML.

The clinical trial is designed to evaluate the **safety**, tolerability, pharmacokinetics, and pharmacodynamics of Tuspetinib (HM43239) in patients with **relapsed or refractory acute myeloid leukemia** (AML). The trial follows a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from July 3, 2023, to April 30, 2024, encompassing both the recruitment and active phases of the study.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. Regular follow-up visits will be scheduled to monitor the participants' response to the treatment, assess any adverse events, and collect necessary data for pharmacokinetic and pharmacodynamic analysis. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the overall outcomes and safety of the intervention.

The expected length of participant involvement in the trial is contingent upon the individual response to treatment and the overall study timeline. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. The trial is conducted in accordance with ethical standards and regulatory requirements to ensure participant safety and data integrity throughout the study period.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatments comprehensively.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is scheduled to commence recruitment on July 3, 2023, with an estimated end date of April 30, 2024. The trial is categorized under phase 7, indicating a specific stage in the clinical research process. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to determine the treatment's effectiveness. The methodology for measuring efficacy will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design will incorporate appropriate tools and instruments to facilitate accurate efficacy assessments, although these are not specified in the available data.