Phase 1 Study of SHP2 Inhibitor BBP-398 and KRAS-G12C Inhibitor Sotorasib in Advanced Solid Tumors with KRAS-G12C Mutation

The primary objective of this study is to evaluate the safety and tolerability of the **SHP2 inhibitor BBP-398** in combination with the **KRAS-G12C inhibitor Sotorasib** in patients with advanced or metastatic solid tumors harboring a **KRAS-G12C mutation**. This is clinically relevant as it aims to address the therapeutic needs of patients with these specific genetic mutations, which are often associated with poor prognosis and limited treatment options. The study focuses on patients with advanced or metastatic non-small cell lung cancer (NSCLC) who are KRAS-G12C inhibitor-naïve, providing insights into the potential efficacy of this combination therapy in a previously untreated population.

The clinical trial involves a total of **35 participants** diagnosed with **advanced or metastatic solid tumors** harboring a **KRAS-G12C mutation**, including those with **advanced or metastatic non-small cell lung cancer (NSCLC)** who are **KRAS-G12Ci naïve**. The study population comprises both male and female subjects, with an age range that includes adults and older adults. Participants were selected based on their medical condition, and the trial includes a vulnerable population. The trial does not specify particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective or specific inclusion criteria for the study.

The clinical trial is designed to evaluate the efficacy and safety of a **SHP2 inhibitor** in combination with a **KRAS-G12C inhibitor** in patients with advanced or metastatic solid tumors harboring a **KRAS-G12C mutation**. This study is a Phase 3, randomized, double-blind, controlled trial, with an estimated recruitment start date of January 10, 2023, and an anticipated completion date of June 1, 2025. The trial targets patients with advanced or metastatic non-small cell lung cancer (NSCLC) who are KRAS-G12Ci naïve, as well as those with other advanced solid tumors with the specified mutation.

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 to receive either the investigational combination therapy or a control treatment. The trial will include multiple follow-up visits to monitor the participants' response to treatment, assess safety, and collect data on any adverse events. These visits will occur at regular intervals throughout the study duration.

The end-of-study visit will mark the conclusion of the participant's involvement in the trial, during which final assessments will be conducted to evaluate the overall outcomes of the treatment. The expected length of participant involvement will vary depending on individual response and tolerance to the treatment, but it is anticipated to last until the study's completion in June 2025. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on January 10, 2023, with an estimated end date of June 1, 2025. The efficacy of the investigational treatment will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology to measure, collect, and analyze these efficacy parameters at predetermined timepoints throughout the study duration. The trial's design and execution will adhere to rigorous standards to ensure the reliability and validity of the efficacy assessments. The results will contribute to understanding the treatment's potential benefits and inform future clinical and therapeutic decisions.