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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)

Trial Status: Active

The primary objective of this trial is to determine the maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D) of BI 1701963 as monotherapy and in combination with trametinib in patients with KRAS mutated solid tumours. Secondary objectives are to evaluate the safety and tolerability of BI 1701963 as monotherapy and in combination with trametinib, to characterise pharmacokinetics and pharmacodynamics, and to evaluate first efficacy signals.

Inclusion Criteria

  • Inclusion criteria: All parts - Previously-identified activating Kirsten rat sarcoma viral oncogene homologue (KRAS) mutation in tumour tissue - 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


M D Anderson Cancer Center
Status: ACTIVE
Contact: Shubham Pant
Phone: 713-563-2476

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Boehringer Ingelheim Pharmaceuticals Inc

  • Primary ID 1432-0001
  • Secondary IDs NCI-2020-02023, 2018-004757-24
  • ID NCT04111458