This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment.

Official Title

An Open Label, Phase I Dose-finding Study of BI 754111 in Combination With BI 754091 in Patients With Advanced Solid Cancers Followed by Expansion Cohorts at the Selected Dose of the Combination in Patients With Non-small Cell Lung Cancer and Other Solid Tumours

Summary:

This study tests the new medicine BI 754111 alone or in combination with BI 754091 in patients with advanced cancer. The study tests different doses to find the best dose for continuous treatment

Trial Description

Primary Outcome:

  • Part I - Maximum-tolerated dose (MTD) of the BI 754111 plus BI 754091 combination
  • Part I - Number of patients experiencing Dose-limiting toxicity (DLTs) during the combination Maximum-tolerated dose (MTD) evaluation period (first cycle of BI 754111 plus BI 754091 combination therapy) in patients with solid tumours
  • Part II - Objective response (OR) - confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 as assessed by the Investigator during the entire treatment
Secondary Outcome:
  • Part I - Cmax: maximum measured concentration of BI 754111/ BI 754091 in plasma
  • Part I - AUC 0-504: Area under the Concentration Time Curve (AUC 0-504) of BI 754111/ BI 754091 in plasma over the time interval
  • Part I - Number of patients experiencing Dose-limiting toxicity (DLTs) from start of treatment until end of treatment (in all cycles)
  • Part I - Objective response (OR) for patients with solid tumours: confirmed complete response (CR) and partial response (PR) according to RECIST Version 1.1 as assessed by the Investigator during the entire treatment period
  • Part II - Duration of response is the duration from the date of first documented PR or CR according to RECIST Version 1.1 as assessed by the Investigator to the date of Progression of disease [PD] or death
  • Part II - Disease control (CR, PR, or SD according to RECIST Version 1.1) as assessed by the Investigator
  • Part II - Progression-free survival (PFS) is the duration from the date of first treatment to the date of PD or death
  • Part II - PK parameters: Cmax, and AUC 0-504, will be calculated for BI 754111 and BI 754091 after single and multiple doses of the BI 754111 plus BI 754091 combination treatment
  • Part II - Number of patients experiencing DLTs from start of treatment until end of treatment

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society