A Phase I/II Study of KISIMA-02 Vaccine-Based Immunotherapy in KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma Patients

The primary objective of this study is to evaluate the efficacy of the **KISIMA-02 vaccine-based immunotherapy** in patients diagnosed with **KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma**. This objective is clinically relevant as it aims to determine the potential of this novel immunotherapy to improve treatment outcomes in a subset of pancreatic cancer patients with specific genetic mutations, which are known to be challenging to treat with conventional therapies.

The clinical trial involves a total of **48 participants** diagnosed with **KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected to include a vulnerable population, although specific criteria for vulnerability are not detailed. The trial does not specify particular lifestyle considerations such as diet or physical activity. The selection process for the trial population is not explicitly described, and key inclusion or exclusion criteria are not provided by the sponsor.

The clinical trial is designed to evaluate a **vaccine-based immunotherapy** for patients with **KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma**. This study is a Phase 1 trial, which is typically focused on assessing the safety, tolerability, and optimal dosing of the investigational treatment. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thereby minimizing bias. The estimated recruitment start date is October 1, 2024, with an anticipated end date of December 31, 2027, indicating a total trial duration of approximately three years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on specific criteria. This initial visit will involve a comprehensive assessment, including medical history, physical examination, and laboratory tests. Following successful screening, participants will be randomized into treatment groups. Throughout the trial, there will be scheduled follow-up visits to monitor the participants' health, assess the treatment's effects, and collect data on any adverse events. These visits are crucial for ensuring participant safety and evaluating the investigational therapy's efficacy. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data on the treatment's impact.

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 reactions, if the disease progresses, or if they choose to withdraw consent. The trial's design and procedures are meticulously planned to ensure the collection of reliable data while prioritizing participant safety and well-being.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatments comprehensively.

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 October 1, 2024, with an anticipated end date of December 31, 2027. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. The trial will likely employ standard methods for data collection and analysis, consistent with Phase 1 objectives, to gather initial insights into the treatment's potential effectiveness. The absence of detailed endpoints suggests a focus on exploratory outcomes, which may include biomarker assessments or preliminary symptom evaluations, depending on the investigational product and disease context. The trial's design will adhere to rigorous scientific and ethical standards to ensure the reliability and validity of the findings.