A Phase 1a/1b Study of the Safety, Pharmacokinetics, and Antitumor Activity of BG-75202 as Monotherapy and in Combination Therapy in Patients with Advanced Solid Tumors

The primary objective of this Phase 1a/1b study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BG-75202, administered as a monotherapy or in combination with other therapeutic agents, in patients presenting with advanced solid tumors. This investigation is clinically significant for determining the dose-limiting toxicities and the pharmacological profile necessary to establish safe dosing regimens. Secondary objectives include the assessment of preliminary antitumor activity to identify potential clinical efficacy in this patient population.

The study involves a total of 71 patients. The population consists of both males and females. Participants are identified within the age range of 3 to 4 years. The cohort is characterized by the presence of advanced and metastatic solid tumors. This study population is classified as vulnerable. The sponsor did not provide information regarding lifestyle considerations or specific selection processes.

This Phase 1 clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-75202, administered as a monotherapy or in combination with other agents. The study focuses on patients diagnosed with advanced solid tumors. The research methodology involves an assessment of the drug's profile through various study stages. The sequence of procedures begins with a screening visit to determine eligibility. Subsequent follow-up visits are conducted to monitor clinical responses and safety parameters. The process concludes with an end-of-study visit. The total duration of the trial is estimated to span from April 2026 to July 2036. Specific conditions leading to early termination are governed by the clinical protocol to ensure participant safety.

Efficacy in the treatment of advanced and metastatic solid tumors is to be evaluated within this Phase 1 clinical trial. Assessment protocols will focus on established clinical parameters appropriate for oncology research.