Phase 1 Evaluation of HMPL-306 in Advanced Hematological Malignancies with Isocitrate Dehydrogenase Mutations

The primary objective of this Phase 1 study is to evaluate the safety and tolerability of **HMPL-306** in patients with advanced hematological malignancies characterized by **isocitrate dehydrogenase (IDH) mutations**. This is clinically relevant as IDH mutations are implicated in the pathogenesis of several hematological cancers, and understanding the safety profile of HMPL-306 could inform future therapeutic strategies. The study focuses on conditions such as acute myeloid leukemia, myelodysplastic syndrome/myeloproliferative neoplasm, angio-immunoblastic T-cell lymphoma, and other mIDH-positive hematological malignancies.

The clinical trial involves a total of **9 participants** diagnosed with various **hematological malignancies**, including acute myeloid leukemia, myelodysplastic syndrome/myeloproliferative neoplasm, angio-immunoblastic T-cell lymphoma, and other mIDH-positive conditions. The study population comprises both male and female subjects, with an age range that includes adults and older adults. Participants were selected based on specific criteria, although the principal inclusion criteria were not provided. The trial includes a vulnerable population, indicating that special considerations may be necessary for their participation. Information regarding lifestyle factors such as diet, physical activity, or habits was not disclosed by the sponsor.

The clinical trial is designed as a **Phase 1** study to evaluate the safety and efficacy of HMPL-306 in patients with advanced hematological malignancies characterized by **isocitrate dehydrogenase (IDH) mutations**. The study will include participants diagnosed with conditions such as **acute myeloid leukemia**, **myelodysplastic syndrome/myeloproliferative neoplasm**, **angio-immunoblastic T-cell lymphoma**, and other mIDH-positive hematological malignancies. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thus minimizing bias.

The trial is expected to commence recruitment on February 9, 2021, and is projected to conclude by June 5, 2025. Participants will be involved in the study for a duration that aligns with the trial's timeline, subject to their continued eligibility and adherence to the study protocol. The sequence of study visits will begin with an inclusion (screening) visit, where potential participants will be assessed for eligibility based on predefined criteria. Following successful screening, participants will undergo a series of follow-up visits at regular intervals to monitor their response to the treatment and any adverse effects. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the treatment.

Participants may be subject to early termination from the study if they experience significant adverse events, fail to comply with the study protocol, or if the investigator deems it in the participant's best interest to withdraw. The study's design and procedures are meticulously crafted to ensure the collection of reliable data while prioritizing participant safety and well-being throughout the trial duration.

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 the administration of other medicinal products or their role in the trial.

Due to the lack of available data, no additional relevant information about drug administration, dosing schedules, or participant compliance monitoring can be described. The absence of these details limits the ability to provide a comprehensive overview of the treatments involved in the clinical trial.

The clinical trial is in Phase 3 and is scheduled to conclude on June 5, 2025. The recruitment for the trial began on February 9, 2021. The trial is categorized under trial category 1, with a trial category ID of 40887. The efficacy of the intervention will be assessed through parameters that are not specified in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not detailed in the available information. The trial does not specify the use of any particular tools or instruments for efficacy assessments. The description of the endpoints, whether primary or secondary, is not provided in the source material.