This Study Aims to Find the Best Dose of BI 907828 in Patients With Different Types of Advanced Cancer (Solid Tumours)

Official Title

A Phase I, Open Label, Multicentre, Dose-escalation Study of BI 907828 in Adult Patients With Wild-type TP53 Enriched Advanced Solid Tumours and Expansion in Patients With MDM2 Amplified Advanced Solid Tumours.

Summary:

Phase Ia - The main objective of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD), based on the frequency of patients experiencing dose limiting toxicities (DLT) during the first treatment cycle, and the recommended dose for expansion (RDE) of BI 907828 monotherapy, and to evaluate its safety and tolerability, by monitoring the occurrence and severity of adverse events (AEs), in two different schedules (Arm A with one single dose every 21 days, Arm B with one single dose on Days 1 and 8, every 28 days). The secondary objectives are the determination of the pharmacokinetic (PK) profile of BI 907828 monotherapy, and the preliminary assessment of anti-tumour activity in patients with advanced or metastatic solid tumours. Phase Ib - In the expansion cohorts of the trial, the main objectives are to assess efficacy, and to further assess the safety, and PK profiles at the RDE, and determine the recommended Phase 2 dose (RP2D).

Trial Description

Primary Outcome:

  • Phase Ia- MTD based on number of patients with DLTs during first treatment cycle
  • Ph Ib - Objective response per RECIST, RANO criteria, or RANO-BM, and assessed by Investigator, measured separately for each cohort, from treatment start until earliest of progression, death, or last tumour assessment and before subsequent therapy
  • Phase Ia - Number of patients with DLTs during first treatment cycle (21 days, Arm A; 28 days, Arm B)
Secondary Outcome:
  • Phase Ia- Cmax: maximum measured concentration of BI 907828 in plasma
  • Phase Ia - AUC0-∞: area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity.
  • Phase Ib - Disease control (DC) with tumour assessment until disease progression (according to RECIST v.1.1 for non-brain lesions, or RANO/RANO-BM- criteria for brain lesions) as assessed by the Investigator, or start of subsequent anti-cancer treatment
  • Phase Ib - Progression-free Survival defined from date of start of BI 907828 to earliest of date of disease progression or death (according to RECIST 1.1, RANO/RANO-BM as applicable), as assessed by the Investigator, measured separately for each cohort.
  • Phase Ib - Number of patients with Grade ≥3 treatment-related adverse events observed during the entire treatment period.
  • Phase Ib - Cmax: maximum measured concentration of BI 907828 in plasma
  • Phase Ib - AUC0-∞: area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity

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