Phase I Study of OT-A201 in Patients with Relapsed/Refractory Hematological Malignancies or Advanced/Metastatic Solid Tumors

The primary objective of this study is to evaluate the safety and tolerability of **OT-A201** in patients with **relapsed/refractory hematological malignancies** or **advanced/metastatic solid tumors**. This is clinically relevant as it aims to determine the potential therapeutic benefits and risks associated with OT-A201 in a population with limited treatment options. The study will provide critical insights into the drug's safety profile, which is essential for further clinical development.

The clinical trial involves participants diagnosed with **relapsed/refractory hematological malignancies** or advanced/metastatic solid tumors. The study population includes both male and female subjects, with an age range encompassing adults and older adults. The trial specifically includes a vulnerable population, although the sponsor has not provided the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been detailed by the sponsor. The trial population was selected to include individuals with the specified medical conditions, but further inclusion or exclusion criteria have not been disclosed.

This clinical trial is a **Phase 1** study designed to evaluate the safety and efficacy of OT-A201 in patients with **relapsed/refractory hematological malignancies** or **advanced/metastatic solid tumors**. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from June 6, 2023, to December 31, 2025, allowing for comprehensive data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough review of the patient's medical history and current health status. Following successful screening, participants will be enrolled in the study and randomly assigned to receive either the investigational product or a control. Throughout the trial, participants will attend regular follow-up visits to monitor their response to the treatment and to identify any adverse effects. These visits will include clinical assessments, laboratory tests, and imaging studies as necessary.

The end-of-study visit will mark the conclusion of the participant's involvement in the trial. During this visit, final evaluations will be conducted to assess the overall impact of the treatment. The expected length of participant involvement will vary depending on individual response and the progression of the disease, but it is anticipated to last until the end of the trial period. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its **pharmaceutical form**, dosage, route, or frequency of administration. Additionally, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, that may be used in the study. Furthermore, the documentation lacks details on drug administration, dosing schedules, and participant compliance monitoring. As such, no further description of the treatments used in this clinical trial can be provided based on the available data.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is June 6, 2023, with an anticipated end date of December 31, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy through various measures, which may include symptom improvement scores, biomarker levels, or other relevant clinical indicators. The methods for measuring and analyzing these parameters are not specified, but they generally involve validated scales, laboratory tests, or patient-reported outcomes collected at predetermined timepoints throughout the study. The trial's efficacy assessments are expected to be conducted using standardized tools and instruments appropriate for the medical condition under investigation, ensuring the reliability and validity of the collected data.