Phase 0 Basket Trial of PET Imaging with Vartumabs F8scFv and C9scFv in Patients with Multiple Solid Tumors

The primary objective of this study is to evaluate the **PET-imaging** of two Vartumabs, F8scFv and C9scFv, in patients with multiple **solid tumors**. These tumors include colorectal carcinoma, pancreatic carcinoma, oesophageal or gastric carcinoma, head and neck squamous cell carcinoma, chondrosarcoma or osteosarcoma, bladder carcinoma, lung carcinoma, and glioblastoma. The clinical relevance of this objective lies in its potential to enhance diagnostic imaging techniques, thereby improving the detection and characterization of various solid tumors. This could lead to more accurate staging and treatment planning, ultimately impacting patient outcomes.

The clinical trial involves participants diagnosed with **multiple solid tumors**, including colorectal carcinoma, pancreatic carcinoma, oesophageal or gastric carcinoma, head and neck squamous cell carcinoma, chondrosarcoma or osteosarcoma, bladder carcinoma, lung carcinoma, and glioblastoma. The study population comprises both male and female subjects, with an age range that includes 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 trial aims to gather data from a diverse group of individuals affected by these conditions, although the main objective of the trial has not been detailed.

The clinical trial is designed as a **Phase 0 basket trial** to evaluate PET-imaging of two Vartumabs, F8scFv and C9scFv, in patients with multiple **solid tumors**. The study will include patients with various types of solid tumors, such as colorectal carcinoma, pancreatic carcinoma, oesophageal or gastric carcinoma, head and neck squamous cell carcinoma, chondrosarcoma or osteosarcoma, bladder carcinoma, lung carcinoma, and glioblastoma. The trial is set to commence recruitment on October 1, 2024, and is expected to conclude by January 31, 2026.

The trial will follow a **randomized, double-blind, controlled** design to ensure the reliability and validity of the results. 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 different study arms. The trial will include multiple follow-up visits to monitor the participants' response to the investigational imaging agents and to collect necessary data. The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted.

The expected duration of participant involvement in the trial will vary depending on the individual response and the specific protocol requirements. However, participants are generally expected to remain in the study until the end-of-study visit unless specific conditions necessitate early termination. Such conditions may include adverse events, withdrawal of consent, or any other protocol-defined criteria that compromise the safety or integrity of the study. The trial's methodology and design are structured to ensure the collection of high-quality data while maintaining participant safety and adherence to ethical standards.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the **disease** being studied, the trial's main objective, or any other pertinent details that would typically be included in a 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 October 1, 2024, with an anticipated end date of January 31, 2026. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. These assessments may include the use of validated scales, laboratory tests, or patient-reported outcomes to measure potential therapeutic effects. The schedule for measuring and collecting efficacy data is not specified, but it is common in clinical trials to have predefined timepoints for data collection to ensure consistency and reliability in the analysis. The analysis of efficacy data will likely involve statistical methods appropriate for the trial phase and objectives, although specific methodologies are not provided. The trial's focus on early-stage evaluation suggests that efficacy assessments will be exploratory, aiming to inform subsequent phases of clinical development.