Evaluation of Click-Cleavable Imaging Agents in HER2-Positive Tumors: The CleavHER Trial

The primary objective of the CleavHER trial is to evaluate the efficacy of **click-cleavable imaging** in patients with **HER2-positive tumors**. This study aims to determine the potential of this imaging technique to enhance the visualization of HER2-positive cancerous tissues, which is clinically relevant for improving diagnostic accuracy and treatment planning in oncology. The trial does not specify any secondary objectives.

The clinical trial involves participants diagnosed with **HER2-positive tumors**. The study population includes both male and female subjects, with an age range spanning from adolescents to adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the efficacy and safety of a novel imaging technique in patients with **HER2-positive tumors**. This study is structured as a Phase 1 trial, which is typically focused on assessing the safety, tolerability, and optimal dosing of the intervention. The trial is expected to commence recruitment on September 1, 2025, and is projected to conclude by December 31, 2026. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results, minimizing bias and allowing for a robust comparison between the intervention and control groups.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This initial visit will involve a comprehensive assessment, including medical history, physical examination, and necessary laboratory tests. Following successful screening, participants will be randomized into the study arms. Throughout the trial, participants will attend regular follow-up visits, which will be scheduled at specific intervals to monitor their health status, assess the intervention's effects, and collect data on any adverse events. These visits are crucial for ensuring participant safety and the integrity of the trial data.

The end-of-study visit will mark the conclusion of a participant's involvement in the trial. During this visit, a final evaluation will be conducted to gather endpoint data and ensure the participant's well-being post-intervention. The expected length of participant involvement will vary depending on the specific protocol requirements but will generally span the duration of the trial. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent, or any other situation deemed necessary by the investigator to protect the participant's health and safety.

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, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is September 1, 2025, with an anticipated end date of December 31, 2026. Although specific efficacy parameters such as primary or 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 gather data on the investigational product's 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.