Phase I Trial Evaluating Eftilagimod Alpha with Immunotherapeutic, Targeted, or Chemotherapeutic Agents in Advanced Solid Tumors

The primary objective of the study is to evaluate the **feasibility** and **safety** of eftilagimod alpha (IMP321), a LAG-3Ig fusion protein acting as a LAG-3 agonist, when used in combination with immunotherapeutic, targeted, or chemotherapeutic agents, or when administered via new routes of application in patients with advanced stage solid tumors. This is clinically relevant as it aims to determine the potential of eftilagimod alpha to enhance the efficacy of existing cancer treatments and explore new administration methods, which could lead to improved therapeutic outcomes for patients with challenging cancer types.

The clinical trial involves participants diagnosed with **locally advanced or metastatic solid tumors**, including specific subtypes such as non-small cell lung cancer (NSCLC) adenocarcinomas and metastatic or irresectable locally advanced urothelial carcinomas. The study population comprises both male and female subjects, with an age range that includes adults and older adults. The trial includes a vulnerable population, although specific details regarding the selection process or lifestyle considerations such as diet and physical activity are not provided. The sponsor has not disclosed the total number of participants involved in the study.

The clinical trial is designed as an explorative, open-labeled, phase I study to evaluate the feasibility and safety of **eftilagimod alpha** in combination with various immunotherapeutic, targeted, or chemotherapeutic agents, or when administered via new routes in patients with advanced stage solid tumors. The trial is set to run from September 11, 2017, to an estimated completion date of September 30, 2026. Participants will be individuals with histologically confirmed locally advanced or metastatic solid tumors, including specific subgroups such as patients with non-small cell lung cancer (NSCLC) adenocarcinomas and metastatic or irresectable locally advanced urothelial carcinomas.

The trial will involve a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on the trial's inclusion and exclusion criteria. Following successful screening, participants will undergo a series of follow-up visits to monitor the safety and efficacy of the treatment regimen. These visits will include assessments of tumor response, adverse events, and overall health status. The end-of-study visit will conclude the participant's involvement, where final evaluations will be conducted to gather comprehensive data on the treatment's impact.

Participant involvement is expected to last throughout the trial duration unless early termination is warranted. Conditions that may lead to early termination include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial's open-label design allows for direct observation of treatment effects, providing valuable insights into the potential benefits and risks associated with the investigational therapy. The study aims to contribute to the understanding of eftilagimod alpha's role in treating advanced solid tumors, potentially informing future therapeutic strategies.

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 the administration of other medicinal products or their role in the trial.

Due to the lack of available data, further information on drug administration, dosing schedules, and participant compliance monitoring cannot be described. The absence of these details limits the ability to provide a comprehensive overview of the treatments involved in the clinical trial.

The clinical trial is in Phase 3 and is expected to conclude by September 30, 2026. The recruitment for the trial began on September 11, 2017. 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 49685. 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 effectiveness. The trial will adhere to the established protocols for data collection and analysis, although specific tools or instruments for efficacy assessments are not mentioned in the provided information.