Safety and Efficacy of DGKζ Inhibitor BGB-30813 and Tislelizumab in Advanced or Metastatic Solid Tumors

The primary objective of this study is to evaluate the **safety** and **tolerability** of the DGKζ inhibitor BGB-30813, both as a monotherapy and in combination with the anti-PD-1 monoclonal antibody Tislelizumab, in patients with **advanced or metastatic solid tumors**. This is clinically relevant as it aims to determine the potential of BGB-30813 to be safely administered to patients, either alone or in combination, which could lead to new therapeutic options for individuals with these challenging cancer types.

The clinical trial involves a total of **149 participants** diagnosed with **advanced or metastatic solid tumors**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. Participants were selected to include a vulnerable population, although specific selection criteria were not disclosed by the sponsor. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The general health status of the participants is not detailed, and no additional key inclusion or exclusion criteria are provided. The sponsor has not disclosed further information regarding the selection process or specific health conditions of the participants.

The clinical trial is designed to evaluate the **safety**, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of the DGKζ inhibitor BGB-30813, both as a monotherapy and in combination with the anti-PD-1 monoclonal antibody Tislelizumab, in patients with advanced or metastatic solid tumors. This is a Phase 1a/1b study, characterized by a randomized, double-blind, and controlled design, ensuring the reliability and validity of the results. The trial is expected to commence recruitment on November 1, 2023, and is projected to conclude by February 28, 2027, encompassing a comprehensive duration to adequately assess the investigational treatments.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be enrolled and randomized into treatment groups. Subsequent follow-up visits will be scheduled at regular intervals to monitor safety, collect pharmacokinetic and pharmacodynamic data, and assess antitumor activity. The end-of-study visit will mark the completion of the participant's involvement, where final assessments will be conducted to gather comprehensive data on the investigational treatments' effects.

The expected length of participant involvement will vary depending on individual response and tolerability, with provisions for early termination in cases of adverse events, disease progression, or withdrawal of consent. The trial's structured approach, with clearly defined visit sequences and objectives, ensures a thorough evaluation of the investigational treatments' potential benefits and risks in the target patient population.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and 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 through a structured evaluation process. The trial is categorized as a Phase 1 study, which typically focuses on assessing safety, tolerability, and pharmacokinetics, but may also include preliminary efficacy assessments. The trial is scheduled to commence recruitment on November 1, 2023, with an estimated completion date of February 28, 2027. Although specific efficacy endpoints are not detailed, Phase 1 trials often utilize various parameters such as **biomarker** levels or symptom improvement scores to gather initial efficacy data. The methods and schedule for measuring, collecting, and analyzing these parameters are not specified, but they generally involve validated scales, laboratory tests, or patient-reported outcomes at predetermined timepoints. The trial will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy data collected.