Phase 1 Dose Escalation Study of IOA-289 with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Cancer

The primary objective of this study is to evaluate the safety and tolerability of **IOA-289** in combination with **gemcitabine/nab-paclitaxel** in patients with **metastatic pancreatic cancer**. This is clinically relevant as it aims to determine the potential of this combination therapy to improve treatment outcomes for patients with this aggressive form of cancer. The study will focus on assessing adverse events, dose-limiting toxicities, and establishing a recommended dose for further clinical trials.

The clinical trial involves a total of **8 participants** diagnosed with **metastatic pancreatic cancer**. The study population includes both male and female subjects, with an age range that spans from young adults to 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. Lifestyle factors such as diet, physical activity, or habits were not specified in the available data. The sponsor did not provide detailed information regarding the general health status of the participants.

The clinical trial is a **Phase 3** study designed to evaluate the safety and efficacy of a combination therapy in patients with **metastatic pancreatic cancer**. 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 August 4, 2022, to February 28, 2025, encompassing both the recruitment and follow-up periods.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This visit is crucial for determining participant suitability based on predefined inclusion and exclusion criteria. Following successful screening, participants will be randomized to receive either the investigational treatment or a control. Throughout the trial, participants will attend regular follow-up visits to monitor treatment response, assess safety, and collect data on primary and secondary endpoints. These visits are scheduled at predetermined intervals to ensure comprehensive data collection and participant safety.

The end-of-study visit marks the conclusion of the participant's involvement in the trial. During this visit, final assessments are conducted, and participants are provided with information regarding their treatment allocation if applicable. The expected length of participant involvement varies depending on individual response and the occurrence of any adverse events. 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 guidelines and regulatory requirements to ensure participant safety and data integrity.

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 this clinical trial, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial documentation may be incomplete or that such information is not applicable to this particular study.

The clinical trial is in Phase 3 and is scheduled to conclude by February 28, 2025. The recruitment for the trial began on August 4, 2022. The efficacy of the investigational treatment will be assessed through a series of predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial is categorized under trial category 1, with a trial category ID of 72108. The assessment of efficacy will be conducted in accordance with the standard practices for Phase 3 clinical trials, ensuring rigorous evaluation of the treatment's impact on the specified medical condition. The trial will adhere to the established protocols for data collection and analysis, although specific tools or instruments for efficacy assessments are not mentioned.