Phase 1 Dose Escalation Study of SGR-2921 Monotherapy in Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome

The primary objective of this study is to evaluate the safety and tolerability of **SGR-2921** as a monotherapy in subjects with relapsed or refractory **Acute Myeloid Leukemia (AML)** and **Myelodysplastic Syndrome (MDS)**. This is a first-in-human, Phase 1, dose escalation study, which is crucial for determining the appropriate dosage and understanding the potential adverse effects of the investigational drug. The clinical relevance of this study lies in its potential to provide a new therapeutic option for patients with these hematologic malignancies, who have limited treatment alternatives due to the relapsed or refractory nature of their disease.

The clinical trial involves a total of **91 participants** diagnosed with **Myelodysplastic syndrome (MDS)** and **Acute Myeloid Leukemia (AML)**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, indicating a diverse age group. Participants were selected to include a vulnerable population, ensuring a comprehensive understanding of the treatment's effects across different demographics. The trial does not specify particular lifestyle considerations such as diet or physical activity. The selection process aimed to encompass a broad spectrum of individuals affected by these hematological conditions, without detailed inclusion or exclusion criteria provided by the sponsor.

This clinical trial is a **Phase 1** dose escalation study designed to evaluate the safety and tolerability of SGR-2921 as a monotherapy in subjects with relapsed or refractory **Acute Myeloid Leukemia (AML)** or **Myelodysplastic Syndrome (MDS)**. The trial employs a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated recruitment start date is January 31, 2024, with an anticipated end date of August 31, 2025, marking the overall trial duration. Participants will be involved in the study for a period that aligns with the trial's timeline, subject to their response to the treatment and adherence to the protocol.

The sequence of study visits begins with an inclusion (screening) visit, where potential participants are 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. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will conclude the participant's involvement, during which 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 effects, fail to comply with the study protocol, or if the investigator deems it necessary for their safety. The study is conducted in accordance with ethical guidelines and regulatory requirements to ensure the well-being of all participants. The trial's design and procedures are structured to provide comprehensive data on the investigational drug's safety profile and potential therapeutic benefits for individuals with AML or MDS.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. Information on parameters or endpoints, methods, schedule for measuring, collecting, and analyzing efficacy parameters, as well as tools or instruments involved in efficacy assessments, is not included. The trial is categorized as Phase 1, with an estimated recruitment start date of January 31, 2024, and an estimated end date of August 31, 2025.