Phase 1 Evaluation of ATV-1601 in Patients with Advanced Solid Tumors and Breast Cancer Harboring AKT1 E17K Mutations

The primary objective of this study is to evaluate the safety and tolerability of **ATV-1601** in patients with advanced solid tumors, including **Breast Cancer**, that harbor **AKT1 E17K mutations**. This is clinically relevant as it aims to determine the potential therapeutic benefit and safety profile of ATV-1601 in a specific genetic subset of cancer patients, which could lead to more targeted and effective treatment options.

The clinical trial involves a total of **70 participants** diagnosed with **advanced solid tumors** and **breast cancer**. The study population includes both male and female subjects, with an age range spanning from young adults to older adults. Participants were selected without targeting any vulnerable populations. The general health status of the participants is not specified, but they are likely to be in a condition that allows for trial participation given the nature of the diseases being studied. No specific lifestyle considerations such as diet, physical activity, or habits are mentioned. The sponsor has not provided detailed information regarding the main objective of the trial or the principal inclusion criteria.

The clinical trial is a **Phase 1** study designed to evaluate the investigational product ATV-1601 in patients with **advanced solid tumors** and **breast cancer** that have AKT1 E17K mutations. 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 October 1, 2025, to August 31, 2028, encompassing both the recruitment and treatment 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 a comprehensive evaluation, including medical history, physical examination, and necessary laboratory tests. Following successful screening, participants will be randomized to receive either the investigational product or a control, with neither the participants nor the investigators aware of the group assignments, maintaining the double-blind nature of the study.

Throughout the trial, participants will attend regular follow-up visits to monitor safety, tolerability, and any potential adverse events. These visits will also include assessments of the investigational product's pharmacokinetics and pharmacodynamics. The frequency and specific procedures of these follow-up visits will be determined by the study protocol, ensuring consistent data collection and participant safety.

The end-of-study visit will mark the conclusion of a participant's involvement in the trial. This visit will include a final evaluation of the participant's health status and any long-term effects of the treatment. The expected length of participant involvement will vary depending on individual response and the study's progression, but it is anticipated to last until the trial's completion in 2028. Conditions that may lead to early termination from the study include significant adverse events, withdrawal of consent, or any other protocol-defined criteria that compromise participant safety or data integrity.

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 addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information, further details about the **experimental medication** and any **non-experimental treatments** used in the study cannot be provided. The trial documentation does not include any additional relevant information about drug administration or participant compliance monitoring.

No specific details regarding the assessment of efficacy in the clinical trial are provided in the source data. Information on parameters or endpoints, methods, schedule for measuring, collecting, and analyzing efficacy parameters, as well as tools or instruments involved in efficacy assessments, is not available. The trial is categorized as Phase 1, with an estimated recruitment start date of October 1, 2025, and an estimated end date of August 31, 2028.