Phase I Evaluation of [177Lu]Lu-OncoFAP-23 and L19-IL2 in Metastatic FAP-Positive Solid Tumors

The primary objective of this phase I study is to evaluate the **safety** and preliminary signs of **efficacy** of [177Lu]Lu-OncoFAP-23, both as a monotherapy and in combination with L19-IL2, in the treatment of patients with advanced or metastatic **FAP-positive solid tumors**. This investigation is clinically relevant as it aims to address the therapeutic needs of patients with these challenging tumor types, potentially offering new treatment avenues. The study focuses on assessing the tolerability and initial therapeutic impact of the investigational agents, which could inform future clinical development and treatment strategies for this patient population.

The clinical trial involves participants diagnosed with **advanced/metastatic FAP-positive tumors**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population have not been disclosed, and no principal inclusion criteria have been specified. The absence of this data limits the ability to provide a comprehensive overview of the participant demographics and selection process.

The clinical trial is designed to evaluate the **safety** and preliminary signs of efficacy of [177Lu]Lu-OncoFAP-23, both as a monotherapy and in combination with L19-IL2, in patients with advanced or metastatic **FAP-positive tumors**. This is a phase I trial, which will be conducted as a randomized, double-blind, controlled study. The trial is expected to commence recruitment on July 1, 2024, and is estimated to conclude by July 1, 2026, making the overall trial duration approximately two years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. The study will include multiple follow-up visits to monitor safety, collect efficacy data, and assess any adverse events. These visits will be scheduled at regular intervals throughout the trial period. The end-of-study visit will occur after the final treatment cycle, where comprehensive assessments will be conducted to evaluate the overall outcomes of the intervention.

The expected length of participant involvement will vary depending on individual response to treatment and the specific protocol requirements. However, participants are generally expected to remain in the study for the duration of the treatment period and follow-up phase. 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 will adhere to strict ethical guidelines and regulatory standards to ensure participant safety and data integrity throughout the study.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided dataset. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of July 1, 2024, and an estimated end date of July 1, 2026. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to determine the treatment's impact. The methods for measuring and analyzing efficacy will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design will focus on gathering comprehensive data to evaluate the treatment's potential benefits and inform future research phases.