Dose-Escalation Study of BI 3810944 in Patients with Advanced Melanoma and Solid Tumors

The primary objective of this study is to evaluate the efficacy and dose response of BI 3810944 in patients diagnosed with advanced solid tumours, including melanoma. Determining the optimal dosage is clinically significant for establishing the therapeutic potential of the investigational product in managing advanced malignancies.

This clinical trial involves a total of 13 patients. The study population includes both males and females within the age ranges corresponding to codes 3 and 4. Participants are diagnosed with melanoma or other solid tumours. The sponsor did not provide additional information regarding lifestyle considerations or specific selection processes.

This Phase 1 clinical trial is designed to evaluate the efficacy and safety of various doses of BI 3810944 in individuals diagnosed with advanced solid tumours, including melanoma. The research methodology involves testing different dosage levels to determine the optimal therapeutic range. The study process begins with a screening visit to assess eligibility for participation. Following successful screening, participants will attend scheduled follow-up visits to monitor clinical responses and safety parameters. The protocol concludes with an end-of-study visit. The duration of involvement for each participant is determined by the specific follow-up schedule required by the study design. Conditions leading to early termination from the study include clinical criteria or safety concerns as defined by the protocol.

The assessment of efficacy in this phase 1 clinical trial focuses on subjects with melanoma or other solid tumours. Specific parameters for evaluating therapeutic response are not defined in the provided documentation.