A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours

Official Title

An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics, and Efficacy of BI 754091 in Patients With Advanced Solid Tumours


The main objective of the dose-escalation part of the trial is to determine the safety and tolerability, and to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D) of BI 754091 on the basis of patients with dose-limiting toxicities (DLTs) in patients with selected advanced solid malignancies. Safety and tolerability will be evaluated by monitoring the occurrence of adverse events (AEs), serious AEs (SAE), and laboratory parameter abnormalities, as well as changes to vital signs. Secondary objectives are the determination of the PK profile of BI 754091 after single and multiple doses of BI 754091, and the preliminary assessment of antitumour activity. In the dose-expansion part of the trial, the main objectives are to further assess the safety, efficacy, PK profile, and biomarkers of BI 754091 in tumours with specific tumour types and/or genetic mutations at the RP2D.

Trial Description

Primary Outcome:

  • Phase 1a: Number of patients experiencing Dose Limiting Toxicity graded according to CTCAE Version 5.0, observed in the first cycle (3 weeks) in order to meet the objective of assessment of the Maximum-tolerated Dose of BI 754091.
  • Phase 1b: Number of patients with Dose Limiting Toxicity observed during the entire treatment period.
  • Phase 1b: Objective response (OR)
Secondary Outcome:
  • Phase 1a: maximum measured concentration (Cmax) of BI 754091 in plasma (if feasible)
  • Phase 1a: area under the concentration-time curve (AUC0-504) of BI 754091 in plasma over the time interval from 0 to 504 hours (if feasible)
  • Phase 1a: Objective response (OR) according to RECIST v1.1 as assessed by the Investigator)
  • Phase 1a: Number of patients experiencing Dose Limiting Toxicities from the start of treatment until end of treatment (in all cycles) as assessed approximately every 3 weeks.
  • Phase 1b: Progression-free survival (PFS) defined from date of start of BI 754091 to the date of disease progression or death, whichever is earlier, according to RECIST v1.1 as assessed by the Investigator
  • Phase 1b: Safety will continue to be assessed by the recording of Adverse Events (AEs), Serious AEs (SAEs) (including Dose Limiting Toxicities), laboratory evaluations, vital signs, and Electrocardiograms

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society