Safety, Tolerability, and Pharmacokinetics of Inavolisib Alone and in Combination with Endocrine and Targeted Therapies in Advanced Breast Cancer and Solid Tumors

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of Inavolisib as a single agent in participants with advanced or metastatic **solid tumors** and in combination with endocrine and targeted therapies in participants with advanced or metastatic **breast cancer**. This evaluation is clinically relevant as it aims to determine the potential therapeutic benefits and risks associated with Inavolisib, which could inform treatment strategies for these conditions.

The clinical trial involves a total of **156 participants** diagnosed with **advanced or metastatic breast cancer** and other advanced or metastatic solid tumors. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed the main objective of the trial.

The clinical trial is designed to evaluate the **safety**, tolerability, and pharmacokinetics of Inavolisib as a single agent in participants with advanced or metastatic **breast cancer** and other advanced or metastatic solid tumors. The study is a Phase 1 trial, which is typically the initial phase in clinical research aimed at assessing the safety profile of a new drug. The trial employs a randomized, double-blind, and controlled design to ensure unbiased results and reliable data collection. The estimated duration of the trial spans from July 17, 2017, to December 30, 2026, allowing for comprehensive data collection and analysis over an extended period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on specific criteria. This initial visit will involve a thorough assessment of the participant's medical history and current health status. Following successful screening, participants will be enrolled in the study and will attend regular follow-up visits. These visits are scheduled to monitor the participants' response to the treatment, assess any adverse effects, and ensure adherence to the study protocol. The end-of-study visit will mark the conclusion of the participant's involvement, during which final evaluations will be conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement in the trial is contingent upon individual response to the treatment and the overall study timeline. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with the study protocol, or if the study is discontinued for any reason. The trial's design and procedures are structured to prioritize participant safety while ensuring the collection of high-quality data to inform future research and potential therapeutic applications.

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 lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

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 was July 17, 2017, with an anticipated end date of December 30, 2026. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials may involve preliminary assessments of efficacy through various measures. These could include symptom improvement scores, biomarker levels, or other relevant clinical indicators, depending on the investigational product and disease context. The methods for measuring and analyzing these parameters would typically involve validated scales, laboratory tests, or patient-reported outcomes, collected at predefined timepoints throughout the trial duration. The absence of specific endpoints in the provided data suggests that the primary focus may be on safety and tolerability, with efficacy assessments being exploratory in nature.