A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)
- Conditions
- Solid Tumors, KRAS Mutation; SOS1
- Interventions
- Registration Number
- NCT04111458
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a study in adults with advanced cancer (solid tumours) in whom previous chemotherapy was not successful. Only people who have a tumour with a KRAS mutation can participate in the study. A KRAS mutation makes cancer grow faster.
The study tests 2 medicines called BI 1701963 and trametinib. BI 1701963 prevents reactivation of KRAS. In this study, BI 1701963 is given to humans for the first time. Trametinib is an approved medicine (MEK inhibitor).
The purpose of this study is to find out the highest dose of BI 1701963 alone and in combination with trametinib the participants can tolerate. Another purpose is to check whether BI 1701963 in combination with trametinib is able to make tumours shrink.
Participants can stay in the study as long as they benefit from treatment and can tolerate it.
During this time, they get tablets of BI 1701963 and trametinib once daily. The doctors regularly monitor the size of the tumour. Doctors also regularly record any unwanted effects and check participants' health.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 71
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BI 1701963 + Trametinib BI 1701963 - BI 1701963 monotherapy BI 1701963 - BI 1701963 + Trametinib Trametinib -
- Primary Outcome Measures
Name Time Method Dose escalation (Part A) - Maximum tolerated dose (MTD) based on number of dose-limiting toxicities (DLTs) 4 weeks Dose confirmation (Part B) - Number of patients with DLTs during the on-treatment period Up to 3 years Dose confirmation (Part B) and expansion (Part C) - Objective response Up to 3 years
- Secondary Outcome Measures
Name Time Method Dose escalation (Part A), confirmation (Part B) and expansion (Part C) - Pharmacokinetic parameters of BI 1701963: Cmax (maximum measured concentration of the analyte in plasma) Up to 5 weeks Dose escalation (Part A), confirmation (Part B) and expansion (Part C) - Pharmacokinetic parameters of BI 1701963: AUCτ (area under the concentration-time curve over a uniform dosing interval τ) Up to 5 weeks Dose escalation (Part A), confirmation (Part B) and expansion (Part C) - Pharmacokinetic parameters of trametinib: Cmax (maximum measured concentration of the analyte in plasma) Up to 5 weeks Dose escalation (Part A), confirmation (Part B) and expansion (Part C) - Pharmacokinetic parameters of trametinib: AUCτ (area under the concentration-time curve over a uniform dosing interval τ) Up to 5 weeks Dose confirmation (Part B) - Pharmacokinetic parameters of BI 1701963: Cmax (maximum measured concentration of the analyte in plasma) Up to 5 weeks Dose confirmation (Part B) and expansion (Part C) - Progression-free survival 6 months Dose confirmation (Part B) - Pharmacokinetic parameters of BI 1701963: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) Up to 5 weeks Dose confirmation (Part B) - Pharmacokinetic parameters of midazolam: Cmax (maximum measured concentration of the analyte in plasma) Up to 5 weeks Dose confirmation (Part B) - Pharmacokinetic parameters of midazolam: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) Up to 5 weeks Dose confirmation (Part B) and expansion (Part C) - Duration of Objective response (OR) Up to 3 years Dose confirmation (Part B) and expansion (Part C) - Tumour shrinkage (in millimetres) Up to 3 years Dose confirmation (Part B) and expansion (Part C) - Number of patients with Grade ≥3 treatment-related adverse events observed during the on-treatment period Up to 3 years Dose confirmation (Part B) - Number of patients with Grade ≥3 treatment-related adverse events observed during the on-treatment period Up to 3 years
Trial Locations
- Locations (8)
Sarah Cannon Research Institute-Nashville-48456
🇺🇸Nashville, Tennessee, United States
Erasmus Medisch Centrum-ROTTERDAM-50697
🇳🇱Rotterdam, Netherlands
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Universitätsklinikum Köln (AöR)
🇩🇪Köln, Germany
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands