Clareo Health | 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)
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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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
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
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 be 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)
Combination part
\- Hypersensitivity to any of the excipients listed in the current Summary of Product Characteristics (SmPC)/Package insert (PI) of trametinib
