Medical Oncology Clinical Trial
Official title:
An Open-label, Non-randomized, Multicenter Phase I Study to Characterize the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose of Oral MKNK1 Inhibitor BAY 1143269 Given Alone or in Combination With Intravenous Docetaxel in Subjects With Advanced Solid Tumors
Determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics (PK), and/or recommended Phase II dose (RP2D) of oral BAY 1143269 given alone or in combination with intravenous (IV) docetaxel in subjects with advanced solid tumors.
BAY 1143269 is a potent and selective, orally administered novel inhibitor of
mitogen-activated protein kinase interacting serine/threonine-protein kinase 1 (MKNK1). MKNK1
activity is essential for the phosphorylation of eukaryotic translation initiation factor 4E
(eIF4E), which promotes the synthesis of oncogenic proteins, inhibits apoptosis, and helps
tumor cells survive under stress. Increased p-EIF4E levels were found in tumor tissues from
cancer patients. MKNK also functions as a mediator of pro-inflammatory cytokine production.
Established anti-mitotic drugs such as vinca alkaloids, taxanes, or epothilones activate the
spindle assembly checkpoint (SAC), a key surveillance mechanism that monitors the attachment
of spindle microtubules to the kinetochores of the chromosomes during pro-metaphase and halts
the transitions to anaphase until all chromosomes are bi-oriented, fully attached, and
correctly tensed at the metaphase plate. These antimitotic drugs destabilize or stabilize the
spindle microtubules and cause mitotic arrest. Prolonged arrest in mitosis forces a cell
either into a mitotic exit without cytokinesis or into a mitotic catastrophe leading to cell
death. MKNK1 inhibitors allow cell apoptosis and increase tumor death. The combination of
taxane and MKNK1 inhibitor can ultimately delay tumor progression and may provide a useful
anticancer therapeutic approach.
This study will attempt to answer the following questions:
- What is the maximum tolerated dose (MTD) of BAY 1143269 when given alone or in
combination with docetaxel?
- What is the safety profile and pharmacokinetics of BAY1143269 when given at the MTD?
- What are the adverse events of BAY 1161909 when given at different dose levels with
docetaxel?
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