Phase 1a/b Study of BGB-58067, an MTA-Cooperative PRMT5 Inhibitor, in Patients with Advanced Solid Tumors with MTAP Deletion or Loss of MTAP Expression

The primary objective of this study is to evaluate the **safety** and **tolerability** of BGB-58067, an MTA-Cooperative PRMT5 Inhibitor, in patients with advanced or metastatic solid tumors characterized by methylthioadenosine phosphorylase (MTAP) homozygous deletion and/or lost MTAP protein expression. This is clinically relevant as it aims to determine the potential of BGB-58067 to be a viable treatment option for these specific tumor types, which are often associated with poor prognosis and limited treatment options.

The clinical trial involves a total of **96 participants** diagnosed with advanced or metastatic solid tumors characterized by **methylthioadenosine phosphorylase (MTAP)** homozygous deletion and/or lost MTAP protein expression. The study population includes both male and female subjects, encompassing an age range that includes adults and older adults. Participants were selected based on the presence of the specified medical condition, with no additional information provided regarding specific lifestyle considerations such as diet or physical activity. The trial includes a vulnerable population, although specific details on the nature of this vulnerability are not disclosed. The selection criteria for the trial population were not detailed by the sponsor.

The clinical trial is a **Phase 1** study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067, an MTA-Cooperative PRMT5 inhibitor, in patients with **advanced solid tumors**. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thereby minimizing bias. The estimated duration of the trial spans from January 31, 2025, to February 28, 2027, allowing for comprehensive data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on specific medical criteria, including the presence of **methylthioadenosine phosphorylase (MTAP)** homozygous deletion or lost MTAP protein expression. Following successful screening, participants will be enrolled and randomized into the study. Regular follow-up visits will be scheduled to monitor the participants' health, assess the drug's effects, and collect necessary data. These visits will include physical examinations, laboratory tests, and imaging studies as required by the protocol. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to evaluate the overall impact of the treatment.

The expected length of participant involvement in the trial is approximately two years, contingent upon individual response and tolerance to the treatment. Conditions that may lead to early termination from the study include significant adverse events, disease progression, or withdrawal of consent by the participant. The trial is designed to ensure participant safety while gathering critical data to advance the understanding of BGB-58067's therapeutic potential in treating advanced solid tumors.

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 data. As such, no further details can be included in this description.

No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. Information such as the parameters or endpoints used to evaluate efficacy, the methods and schedule for measuring, collecting, and analyzing these parameters, and any tools or instruments involved in efficacy assessments are not included. The trial is identified as a Phase 1 study, with an estimated recruitment start date of January 31, 2025, and an estimated end date of February 28, 2027. Further details on efficacy assessment are not available in the provided data.