Evaluation of FS120 Monotherapy and FS120 with Pembrolizumab in Patients with Advanced Malignancies: A First-in-Human Safety and Efficacy Study

The primary objective of this study is to evaluate the **safety** and **anti-cancer activity** of FS120, an antibody medication, in subjects with **advanced malignancies**. This evaluation is crucial for determining the therapeutic potential and safety profile of FS120, both as a monotherapy and in combination with **pembrolizumab**, a known immune checkpoint inhibitor. Understanding the safety and efficacy of FS120 in this context is essential for advancing treatment options for patients with advanced cancer types.

The clinical trial involves a total of **164 participants** diagnosed with **advanced malignancies**. 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 were not provided by the sponsor. The general health status of the participants is characterized by the presence of advanced malignancies, but no additional lifestyle considerations such as diet, physical activity, or habits were specified. The trial aims to gather data from a diverse group of individuals to ensure comprehensive insights into the condition under investigation.

The clinical trial is designed to evaluate the safety and anti-cancer activity of **FS120**, an antibody medication, administered alone or in combination with **Pembrolizumab** in subjects with advanced malignancies. This is a Phase 1 trial, which is typically the first step in testing a new treatment in humans. The trial follows a randomized, double-blind, controlled design to ensure unbiased results and to compare the effects of the investigational drug against a control. The estimated duration of the trial spans from October 3, 2022, to January 7, 2026, 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 visit will involve a thorough review of the participant's medical history and baseline assessments. Following successful screening, participants will be randomized to receive either the investigational drug or a control. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' health, assess the drug's efficacy, and record any adverse events. These visits are crucial for ensuring participant safety and for collecting data on the drug's performance.

The end-of-study visit marks the conclusion of the participant's involvement in the trial. During this visit, final assessments will be conducted to evaluate the overall impact of the treatment. The expected length of participant involvement will vary depending on individual response to the treatment and the occurrence of any adverse events. Participants may be withdrawn from the study early if they experience significant adverse effects, if the disease progresses, or if they choose to withdraw consent. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its **pharmaceutical form**, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included in the trial documentation.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

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 was October 3, 2022, with an anticipated end date of January 7, 2026. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically involve initial assessments of therapeutic effects alongside safety evaluations. The trial will likely employ standard methodologies for data collection and analysis, consistent with Phase 1 objectives, to determine preliminary efficacy outcomes. The absence of detailed endpoints suggests a focus on exploratory measures to inform subsequent trial phases.