Phase 1 Study of OP-3136 in Patients with Advanced or Metastatic Solid Tumors

The primary objective of this phase 1 study is to evaluate the safety and tolerability of OP-3136 in patients diagnosed with advanced or metastatic solid tumors. Determining the safety profile and identifying potential dose-limiting toxicities is essential for establishing the clinical utility of the investigational agent. No secondary objectives were specified.

The study involves a total of 132 patients. The population consists of both males and females. Participants are within the age ranges categorized as 3 and 4. The cohort is characterized by the presence of advanced or metastatic solid tumors.

This Phase 1 clinical trial is designed to evaluate the safety and pharmacokinetics of OP-3136 in patients diagnosed with advanced or metastatic solid tumors. The study follows a structured methodology involving a screening visit to assess eligibility, followed by periodic follow-up visits to monitor clinical responses and safety parameters. The protocol concludes with an end-of-study visit to perform final assessments. Total participant involvement is determined by individual clinical progress and treatment response. Participation may be subject to early termination if specific safety criteria or predefined clinical conditions are met.

The assessment of efficacy in this clinical trial focuses on patients with advanced or metastatic solid tumors. The study aims to evaluate therapeutic response through specified endpoints designed to monitor disease progression and clinical outcomes.