Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Solid Tumors, KRAS Mutation; SOS1
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04111458
Start Date
November 4 2019
End Date
December 31 2025
Last Update
March 25 2025
Active Locations (8)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
2
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
3
Sarah Cannon Research Institute-Nashville-48456
Nashville, Tennessee, United States, 37203
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030