Phase I Study of BI 3923948 Monotherapy and in Combination with an Anti-PD-1 Antibody in Patients with Advanced, Unresectable, or Metastatic Solid Tumors

The primary objective of this study is to evaluate the efficacy and safety of various doses of BI 3923948, administered as a monotherapy or in combination with an anti-PD-1 antibody, in patients presenting with advanced, unresectable and/or metastatic solid tumors. This investigation aims to determine the optimal therapeutic regimen and the clinical impact of combined immunotherapy and targeted intervention on tumor progression.

This clinical trial involves a total of 15 patients. The study population includes both males and females within the age ranges corresponding to codes 3 and 4. Participants are diagnosed with advanced, unresectable and/or metastatic solid tumors. The sponsor did not provide additional information regarding lifestyle considerations or specific selection processes.

This Phase 1 clinical trial is designed to evaluate various doses of BI 3923948, administered either as a monotherapy or in combination with an anti-PD-1 antibody, in individuals diagnosed with advanced solid tumors. The study methodology involves assessing the safety and efficacy of these treatment regimens. The clinical course begins with a screening visit to determine eligibility based on specific criteria. Following successful screening, participants undergo treatment and subsequent follow-up visits to monitor clinical responses and safety profiles. The sequence of procedures concludes with an end-of-study visit. Total participation duration is determined by individual clinical progression and study protocol requirements. Early termination from the study may occur due to predefined safety concerns or clinical criteria.

The assessment of efficacy in this Phase 1 clinical trial involves the evaluation of therapeutic response in subjects with advanced, unresectable, and/or metastatic solid tumors. Specific efficacy parameters and the methodology for their measurement are not defined in the provided documentation.