NEW YORK – Effector Therapeutics on Wednesday said that it has begun dosing patients in the expansion portion of its ongoing Phase I/II trial of zotatifin (eFT226), and that the firm plans to open tumor-specific expansion cohorts enrolling patients with hormone receptor-positive breast cancer and KRAS-mutated non-small cell lung cancer.
The investigational sequence-selective inhibitor zotatifin is designed to block the process of eIF4A-mediated translation, in turn inhibiting the process of mRNAs encoding oncogenes and tumor survival factors. Preclinical studies have suggested that zotatifin can lead to tumor shrinkage in cancers that depend on these factors.
The ongoing Phase I/II trial is designed to evaluate zotatifin as a treatment for biomarker-defined solid tumors. Specifically, for the dose escalation portion, the trial enrolled patients with any advanced or standard treatment-refractory solid tumor harboring activating mutation, amplification, or fusion of HER2, ERBB3, FGFR1, FGFR2, or an activating mutation in KRAS. Patients with pancreatic cancer but no documented molecular biomarker were also eligible to enroll.
Now that Effector has determined a recommended Phase II dose for zotatifin in the trial, the firm will use this dosage to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of the agent — both alone and in combination with various targeted therapies — among the various expansion cohorts.
Effector plans to present data from the dose escalation portion of its zotatifin trial, as well as initial data from the expansion cohorts, during a medical conference next year.