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)

Running, not enrolling · Phase 1

Conditions studied: Solid Tumors, KRAS Mutation; SOS1

In brief

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.

Key facts

Study ID: NCT04111458
Run by: Boehringer Ingelheim
People needed: 71
Starts: 2019-11-04
Expected to finish: 2028-04-30
Last updated by the study team: 2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All parts
Previously-identified activating Kirsten rat sarcoma viral oncogene homologue (KRAS) mutation in tumour tissue or blood prior to screening
At least one target lesion that can be measured per Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function
Age ≥18 years of age, or over the legal age of consent as required by local legislation.
Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial.
Women of childbearing potential who are not surgically sterilized must have a negative serum pregnancy test completed during the Screening period
Further inclusion criteria apply
Monotherapy and combination therapy dose escalation and monotherapy dose confirmation part
Documented disease progression despite appropriate prior standard therapies or for whom no standard therapy exists for their tumour type and disease stage
Combination dose confirmation and expansion cohort
Pathologically confirmed diagnosis of adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
Locally advanced stage IIIb or metastatic stage IV Non-small cell lung cancer (NSCLC)
Patients must have received both chemotherapy and immunotherapy

You may not qualify if…

All parts
Previous anticancer chemotherapy within 3 weeks of the first administration of trial drug.
Previous treatment with RAS, Mitogen-activated protein kinase (MAPK) or Son of sevenless 1 (SOS1) targeting agents
Major surgery performed within 4 weeks prior to start of treatment
Uncontrolled hypertension, congestive heart failure NYHA classification of ≥3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to start of treatment
Left ventricular ejection fraction (LVEF) <50 %
Congenital long QT prolongation syndrome
Mean resting corrected QT interval (QTcF) >470 msec
Leptomeningeal carcinomatosis
Presence or history of uncontrolled or symptomatic brain metastases
Known pre-existing interstitial lung disease
Known active hepatitis B infection (defined as presence of Hep B sAg and/or Hep B Deoxyribonucleic acid (DNA)), active hepatitis C infection (defined as presence of Hep C Ribonucleic acid (RNA))
Active infectious disease
Any history or presence of uncontrolled gastrointestinal disorders that could affect the intake and/or absorption of the trial drug
History of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED)
Further exclusion criteria apply
Combination part
Hypersensitivity to any of the excipients listed in the current Summary of Product Characteristics (SmPC)/Package insert (PI) of trametinib

Where it is running

Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Levine Cancer Institute — Charlotte, North Carolina, United States
Sarah Cannon Research Institute-Nashville-48456 — Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Universitätsklinikum Köln (AöR) — Cologne, Germany
Universitätsklinikum Frankfurt — Frankfurt am Main, Germany
Erasmus Medisch Centrum-ROTTERDAM-50697 — Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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