Phase 0 SPECT/CT Imaging of FPI-2505 in Patients with Solid Tumors: A Molecular Imaging Basket Trial in Lung, Colorectal, Breast, Pancreatic, and Gastric Cancers

The primary objective of this study is to evaluate the efficacy of **SPECT/CT imaging** using FPI-2505 in patients with various **solid tumors**, including **small cell lung cancer**, **non-small cell lung cancer**, **colorectal cancer**, **breast cancer**, **pancreatic cancer**, and **gastric cancer**. This evaluation is clinically relevant as it aims to enhance the diagnostic accuracy and treatment planning for these malignancies, potentially leading to improved patient outcomes.

The clinical trial involves participants diagnosed with **small cell lung cancer**, non-small cell lung cancer, colorectal cancer, breast cancer, pancreatic cancer, and gastric cancer. 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. Selection criteria for the trial population, as well as any lifestyle considerations such as diet or physical activity, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the use of **SPECT/CT imaging** of FPI-2505 in patients with various **solid tumors**, including small cell lung cancer, non-small cell lung cancer, colorectal cancer, breast cancer, pancreatic cancer, and gastric cancer. This is a phase 0 molecular imaging basket trial, which is characterized by its exploratory nature, focusing on the imaging of the investigational product rather than therapeutic outcomes. The trial is structured as a randomized, double-blind, controlled study to ensure the reliability and validity of the results. The estimated duration of the trial is from July 15, 2025, to February 15, 2026, allowing for comprehensive data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough review of the participant's medical history and current health status. Subsequent follow-up visits will be scheduled to monitor the participant's response to the imaging agent and to collect necessary data. These visits will include imaging sessions and any required clinical assessments. The end-of-study visit will mark the conclusion of the participant's involvement, during which final evaluations will be conducted to gather comprehensive data on the imaging outcomes.

The expected length of participant involvement in the trial is approximately seven months, from the initial screening to the end-of-study visit. Participants may be subject to early termination from the study if they experience adverse events that compromise their safety, if they withdraw consent, or if they fail to comply with the study protocol. The trial is conducted under strict ethical guidelines, ensuring that participant safety and data integrity are maintained throughout the study period.

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 not included in the provided dataset. As such, these aspects cannot be detailed in the context of this clinical trial description.

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 July 15, 2025, with an anticipated end date of February 15, 2026. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically involve initial assessments of pharmacokinetics and pharmacodynamics, which may include measuring **biomarker** levels or other relevant physiological responses. The methods and schedule for measuring, collecting, and analyzing these parameters are not specified, but standard practices in Phase 1 trials often involve frequent monitoring and data collection at various timepoints throughout the study duration. The trial's focus on safety and dosage suggests that efficacy assessments will be aligned with these objectives, utilizing appropriate tools and instruments to gather necessary data.