Phase 1b Study of NP137 with mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma

The primary objective of this Phase 1b study is to investigate the association of **NP137** with **mFOLFIRINOX** in patients with locally advanced **pancreatic ductal adenocarcinoma**. This study aims to evaluate the potential therapeutic benefits and safety profile of combining NP137 with the standard chemotherapy regimen mFOLFIRINOX. Understanding this association is clinically relevant as it may offer insights into improved treatment strategies for this aggressive form of cancer, potentially enhancing patient outcomes and survival rates.

The clinical trial involves participants diagnosed with **pancreatic ductal adenocarcinoma**. The study population includes both male and female subjects, with an age range spanning from adults to the elderly. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the association of NP137 with mFOLFIRINOX in patients diagnosed with **pancreatic ductal adenocarcinoma**. This study is structured as a Phase 1b trial, which is a preliminary phase aimed at assessing the safety and potential efficacy of the investigational treatment. The trial is expected to be conducted over a period of approximately five years, with an estimated recruitment start date of October 15, 2022, and an anticipated completion date of October 15, 2027.

The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be randomly assigned to either the treatment group receiving NP137 in combination with mFOLFIRINOX or a control group. The double-blind nature of the study ensures that neither the participants nor the investigators are aware of the group assignments, thereby minimizing bias.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be enrolled in the study and will attend regular follow-up visits to monitor their health status, treatment response, and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the trial. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted.

The expected length of participant involvement in the trial is contingent upon the individual's response to treatment and overall health status. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy within a Phase 3 framework. The trial is scheduled to commence recruitment on October 15, 2022, with an estimated completion date of October 15, 2027. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methodology for measuring efficacy will adhere to standard clinical trial protocols, utilizing validated tools and instruments where applicable. The trial's design aims to provide robust data to evaluate the treatment's effectiveness, contributing to the overall understanding of its clinical benefits.