A study to test different doses of BI 3011441 in Japanese people with different types of advanced cancer (NRAS/KRAS mutation positive)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

Must be at least 20 years of age at screening.
Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial.
Pathologically documented, locally-advanced or metastatic malignancy with previously-identified activating NRAS or KRAS mutation based on local test.
Provision of archival tumor tissue, if available, to confirm retrospectively NRAS or KRAS mutation status and for biomarker assessment.
Willingness to undergo pre- and on-treatment tumour biopsies for pharmacodynamics and biomarker assessment. Patients can be enrolled without tumour biopsy upon agreement between the Investigator and the Sponsor if tumour biopsy is not feasible.
Must have either progressed despite appropriate prior standard therapies or for whom no standard therapy exists for their tumour type and disease stage.
Must have at least one target lesion that can be measured per RECIST version 1.1
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Must show adequate organ function.

Exclusion Criteria

Previous anticancer chemotherapy within 3 weeks of the first administration of trial drug.
Radiotherapy within 4 weeks prior to first administration of BI 3011441.
Major surgery within 4 weeks prior to start of treatment or scheduled during the projected course of the trial.
Previous treatment with a RAS, MAPK targeting agent.
Patients who have a history or current evidence/risk of retinal vein occlusion (RVO) or retinal pigment epithelial detachment or central serous retinopathy.
Patients who have visible retinal pathology that is considered a risk factor for RVO or central serous retinopathy as assessed by ophthalmic examination.
History or presence of cardiovascular abnormalities.
Left ventricular ejection fraction (LVEF) <50 %.
Baseline QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 msec or congenital long QT syndrome
Leptomeningeal carcinomatosis.
Presence or history of uncontrolled or symptomatic brain metastases.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoints<br>Maximum tolerated dose<br>Number of patients with DLTs in the MTD evaluation period.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints<br>Number of patients with DLTs during the entire on-treatment period <br>Number of patients with Grade >= 3 lated adverse events <br>Number of patients with treatment related adverse events at each dose level <br>Pharmacokinetic parameters of BI 3011441: Cmax(,ss) <br>and AUC0-tz(,ss)

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