Phase I Evaluation of Safety and Dosimetry of 68Ga-Labelled OncoFAP Derivatives in Patients with Solid Tumors: Breast, Colorectal, Oesophageal, and Pancreatic Adenocarcinoma

The primary objective of this Phase I study is to evaluate the **safety** and **dosimetry** of 68Ga-labelled OncoFAP derivatives in patients with solid tumors, specifically those diagnosed with **breast cancer**, **colorectal cancer**, **oesophageal cancer**, and **pancreatic adenocarcinoma**. This evaluation is clinically relevant as it aims to determine the potential of 68Ga-labelled OncoFAP derivatives as a diagnostic tool, which could enhance the precision of tumor imaging and improve patient management in these cancer types.

The clinical trial involves participants diagnosed with **breast cancer**, colorectal cancer, oesophageal cancer, and pancreatic adenocarcinoma. 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 population selection criteria and the total number of participants have not been disclosed by the sponsor. The study includes a vulnerable population, indicating that special considerations may be necessary for their participation. No specific lifestyle considerations such as diet, physical activity, or habits have been provided. Key inclusion or exclusion criteria have not been detailed in the available data.

The clinical trial is designed to evaluate the safety and dosimetry of **68Ga-labelled OncoFAP derivatives** in patients diagnosed with solid tumors, specifically targeting individuals with breast cancer, colorectal cancer, oesophageal cancer, and pancreatic adenocarcinoma. This is a Phase I trial, which is typically the initial step in testing a new treatment in humans, focusing on assessing safety, dosage, and side effects. The trial employs a randomized, double-blind, controlled design to ensure unbiased results and reliable data collection. The estimated duration of the trial spans from September 1, 2022, to July 1, 2024, allowing for comprehensive data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This is followed by multiple follow-up visits scheduled at predetermined intervals to monitor the participants' response to the treatment and any potential adverse effects. The trial concludes with an end-of-study visit, where final assessments are conducted to evaluate the overall outcomes of the treatment. The expected length of participant involvement is aligned with the trial's duration, although individual participation may vary based on specific responses to the treatment or unforeseen medical conditions. Conditions that may lead to early termination from the study include significant adverse reactions or the participant's decision to withdraw consent. The trial is structured to ensure the safety and well-being of participants while gathering essential data to advance medical knowledge in the treatment of these cancers.

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 these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is designed to assess the efficacy of the investigational product through a structured evaluation process. The trial is categorized as a Phase 1 study, focusing on initial safety and efficacy assessments. The estimated recruitment start date was September 1, 2022, with an anticipated completion by July 1, 2024. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve the collection of preliminary data on the product's effects, which may include **biomarker** levels or other relevant clinical measures. The trial will likely employ validated scales and laboratory tests to gather data at predetermined intervals throughout the study period. The analysis of these parameters will be conducted to determine the investigational product's potential therapeutic benefits and inform subsequent trial phases.