Evaluation of Safety, Tolerability, and PET Imaging Effects of GEH200520 and GEH200521 (18F) in Patients with Irresectable or Metastatic Solid Tumors

The primary objective of this study is to evaluate the **safety** and **tolerability** of the administration of GEH200520 and GEH200521 (18F) in patients with **irresectable** or **metastatic solid tumours** or a local and resectable **head and neck squamous cell carcinoma**. This is clinically relevant as it aims to determine the potential adverse effects and overall patient tolerance to these compounds, which are crucial for ensuring patient safety and guiding future therapeutic applications. Additionally, the study seeks to assess the effect of these compounds on **PET imaging**, which is important for understanding their potential utility in enhancing diagnostic imaging in oncology. No secondary objectives are provided in the available data.

The clinical trial involves participants diagnosed with **irresectable or metastatic solid tumors** or a local and resectable head and neck squamous cell carcinoma. The study population includes both male and female subjects, encompassing a broad age range from adolescents to adults. The trial also considers vulnerable populations, although specific details regarding the total number of participants have not been provided by the sponsor. Participants were selected based on criteria that include their health status and the presence of the specified medical conditions. Lifestyle factors such as diet, physical activity, and habits are not detailed in the available data. Key inclusion or exclusion criteria are not explicitly mentioned, indicating a focus on the medical condition and demographic characteristics of the participants.

The clinical trial is designed to evaluate the **safety** and tolerability of GEH200520 and GEH200521 (18F) in patients with **irresectable or metastatic solid tumours** or a local and resectable head and neck squamous cell carcinoma. This is a Phase 1 trial, which is randomized, double-blind, and controlled, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thus minimizing bias. The trial is expected to run from August 15, 2022, to December 30, 2025, with the recruitment phase beginning at the start date.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on specific criteria. This visit will involve a comprehensive assessment, including medical history, physical examination, and necessary 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 drug's effects, and ensure adherence to the protocol. These visits will include physical examinations, imaging studies, and laboratory tests to evaluate the primary and secondary endpoints of the study. The end-of-study visit will conclude the trial for each participant, involving a final assessment of safety and efficacy outcomes.

The expected length of participant involvement will vary depending on individual response and adherence to the study protocol. Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with study procedures, or if the investigator deems it necessary for their safety. The trial's design and procedures are structured to ensure the collection of reliable data while prioritizing participant safety and well-being.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In this clinical trial, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial documentation may be incomplete or that such information is not applicable to this particular study.

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 August 15, 2022, and an estimated end date of December 30, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely involve standard methodologies appropriate for a Phase 1 study. These may include the use of validated scales, laboratory tests, or patient-reported outcomes to measure efficacy. The schedule for measuring and collecting data will be aligned with the trial's timeline, ensuring systematic data collection and analysis. The trial's efficacy assessments will be conducted in accordance with established clinical trial protocols, ensuring the reliability and validity of the results.