This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of daily oral administration of eFT508.
eFT508 is an oral, potent and highly selective inhibitor of mitogen-activated protein kinase interacting kinase (MNK) 1 and 2. Dysregulated translation of messenger RNA (mRNA) plays a role in the pathogenesis of multiple solid tumors and hematological malignancies. MNK1 and MNK2 integrate signals from several oncogenic and immune signaling pathways (including RAS, p38 and Toll-like receptors) by phosphorylating eukaryotic initiation of factor 4E (eIF4E) and key effector proteins. Phosphorylation of these regulatory proteins by MNK1 and MNK2 selectively regulates the stability and translation of a subset of cellular mRNA that control tumor growth, the tumor microenvironment and immune signaling. Nonclinical studies indicate that eFT508 shows activity against various types of solid tumors. These nonclinical studies support initiation of clinical development of eFT508 in patients with cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Will be given orally once or twice daily. Each treatment cycle = 21 days.
SCRI at HealthONE
Denver, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Maximum tolerated dose (MTD)/Recommended dose (RD)
Time frame: Up to one year
Overall response rate (ORR)
Time frame: Up to three years
Safety (Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v. 4.03))
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v. 4.03)
Time frame: Up to three year
Plasma concentration of eFT508 as characterized by maximum serum concentration (Cmax)
Time frame: Different time points up to 336 hours
Plasma concentration of eFT508 as characterized by Area Under the Curve (AUC)
Time frame: Different time points up to 336 hours
Changes in eIF4E phosphorylation in peripheral blood cells (PBMCs)
Time frame: Up to Day 14
Tumor control evaluated by modified RECIST criteria v 1.1
Time frame: Up to three years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.