Phase I Dose-Escalation and Expansion Study of BI 3819026 Monotherapy and in Combination with Ezabenlimab in Patients with Unresectable Advanced or Metastatic Solid Tumors

The primary objective of this study is to evaluate the tolerability of various doses of BI 3819026 administered as a monotherapy or in combination with ezabenlimab in patients with unresectable advanced or metastatic solid cancer. Determining the acceptable dose levels is clinically essential for establishing the safety profile and defining the appropriate dosing regimen for future therapeutic interventions in this patient population. Trial scope: 4, 9.

The study involves a total of 48 patients. The population includes both males and females within the specified age ranges. All participants are diagnosed with unresectable advanced or metastatic solid cancer. The sponsor did not provide information regarding lifestyle considerations or the selection process.

This Phase 3 clinical trial is designed to evaluate the tolerability of various doses of BI 3819026, administered either as a single agent or in combination with ezabenlimab, in individuals diagnosed with unresectable advanced or metastatic solid cancer. The study methodology involves a structured sequence of assessments beginning with a screening visit to determine eligibility. Following enrollment, participants will undergo scheduled follow-up visits to monitor safety and tolerability. The study concludes with an end-of-study visit. The total duration of participant involvement is not specified. Early termination from the study may occur based on predefined clinical conditions or safety protocols.

The assessment of efficacy in this phase 3 clinical trial involves the evaluation of outcomes related to unresectable advanced or metastatic solid cancer. Specific parameters and methodologies for measuring therapeutic response are not specified.