Phase I Evaluation of [68Ga]Ga-DWJ155 in Patients with Advanced Breast Cancer and Non-Small Cell Lung Cancer (NSCLC)

The primary objective of this phase I study is to evaluate the safety and tolerability of **[68Ga]Ga-DWJ155** in patients with advanced breast cancer and advanced non-small cell lung cancer (NSCLC). This is clinically relevant as it aims to determine the potential of **[68Ga]Ga-DWJ155** as a diagnostic agent, which could enhance imaging techniques and improve the management of these advanced cancers. No secondary objectives are provided in the available data.

The clinical trial involves participants diagnosed with **advanced breast cancer** and advanced **non-small cell lung cancer (NSCLC)**. 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 include a focus on a vulnerable population, although specific inclusion or exclusion criteria are not provided. The sponsor has not disclosed the total number of participants involved in the study. Information regarding lifestyle considerations such as diet, physical activity, or habits is not available.

The clinical trial is a **phase I** study designed to evaluate the investigational agent [68Ga]Ga-DWJ155 in patients diagnosed with **advanced breast cancer** and **advanced non-small cell lung cancer (NSCLC)**. The trial employs a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from July 1, 2025, to March 4, 2027, encompassing both the recruitment and study phases.

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 comprehensive evaluations to confirm the diagnosis and suitability for trial participation. Following successful screening, participants will be randomized into treatment groups and will attend regular follow-up visits. These visits are scheduled to monitor the safety, tolerability, and preliminary efficacy of the investigational agent. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to gather data on the long-term effects of the treatment.

The expected length of participant involvement in the trial is approximately 20 months, contingent upon individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include adverse events that compromise participant safety, non-compliance with study procedures, or withdrawal of consent. The trial is conducted in accordance with ethical standards and regulatory requirements to ensure the welfare of all participants.

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 initial phase of clinical research focused on evaluating safety, dosage, and potential efficacy. The trial is scheduled to commence recruitment on July 1, 2025, with an estimated completion date of March 4, 2027. Although specific efficacy endpoints are not detailed, Phase 1 trials typically involve the collection of preliminary data on the drug's effects, which may include assessments of pharmacokinetics and pharmacodynamics. The trial will adhere to rigorous protocols to ensure the accurate measurement and analysis of efficacy parameters, utilizing validated methods and instruments appropriate for the investigational product and the condition under study. The data collected will contribute to the understanding of the investigational product's potential therapeutic benefits and inform subsequent phases of clinical development.