BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors

Inclusion Criteria

• •Patients with histologically or cytologically confirmed diagnosis of advanced, measurable or evaluable, non-resectable and/or metastatic solid tumours, which has shown to be progressive;
• •Patients who have received previous standard of care therapy for their disease and have progressed;
• •18 years or older;
• •Life expectancy \>= 3 months;
• •Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation;
• •Eastern Cooperative Oncology Group (ECOG), performance score 0-2.
• •Patients must have confirmed progressive disease within the last 6 months, (in case of measurable disease, progression should be confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1;
• •Patients carrying a tumour for whom treatment with either exemestane or paclitaxel would be considered appropriate by the investigator;
• •Patients must have measurable progressive disease within the last 6 months documented/proven according to RECIST criteria version 1.1.
• •Patients entering the expansion cohorts must also have:
• •Arm A: any advanced/metastatic solid tumour suitable for biopsy and must have provided informed consent for biopsy and biomarker analysis.
• •Arm B: any cytologically or histologically confirmed ER+ (estrogen receptor positive) advanced/metastatic solid tumours for which treatment with exemestane would be considered appropriate by the investigator.
• •Arm C: any advanced/metastatic solid tumour for which treatment with paclitaxel would be considered appropriate by the investigator.