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A phase I open-label trial of BI 3011441 in Japanese patients with NRAS/KRAS mutation positive advanced, unresectable or metastatic refractory solid tumours

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

Katakabe Tetsuya

Nippon Boehringer Ingelheim Co., Ltd.

ThinkPark Tower 2-1-1 Osaki, Shinagawa-ku, Tokyo 141-6017, Japan

zzMEDCDOCHIKEN@boehringer-ingelheim.com

Hosono Tatsunori

Nippon Boehringer Ingelheim Co., Ltd.

ThinkPark Tower 2-1-1 Osaki, Shinagawa-ku, Tokyo 141-6017, Japan

+81-120-189-779

zzMEDCDOCHIKEN@boehringer-ingelheim.com

Not Recruiting

Mar. 19, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Avanced, unresectable, or metastatic refractory solid tumours

Oral administration of BI 3011441 (4mg, 6mg, 7mg, 8mg)

Primary endpoints
Maximum tolerated dose
Number of patients with DLTs in the MTD evaluation period.

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

+81-3-3542-2511

Feb. 17, 2021

No

none