Recruitment anticipated to start in early October
Advanced solid tumor that is refractory or intolerant to standard of care therapy, where the tumor is pancreatic adenocarcinoma (no molecular typing) or any other solid tumor that has a documented activating mutation, amplification, or fusion of HER2, ERBB3, FGFR1, FGFR2, or an activating mutation in KRAS.
eFT226 is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics as an anticancer therapy. eFT226 is a potent and selective inhibitor of eIF4A1-mediated translation and selectively regulates the translation of a subset of mRNAs based on sequence specific recognition motifs in their 5′-UTR. eIF4A1 inhibition by eFT226 downregulates expression of receptor tyrosine kinases and KRAS, leading to decreased signaling through the PI3K/AKT and MAPK pathways. Preclinical efficacy testing of eFT226 demonstrates activity across models of solid tumor cancers with amplifications in HER2, FGFR1/2 and mutations in KRAS (including breast, NSCLC and CRC)
Clinical Trial Description:
This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of eFT226 in subjects with selected advanced solid tumor malignancies. The study will evaluate weekly 1-hour intravenous (IV) administration of eFT226. Treatment and study subject evaluations will be performed in 21 day cycles. Subjects will be assigned sequentially to increasing eFT226 doses. eFT226 doses will be escalated in subsequent cohorts after subjects enrolled in a given cohort have completed the 21-day dose-limiting toxicity (DLT) evaluation period. Dose escalation will enroll subjects based on 3+3 design, whereby 3 subjects will be initially enrolled and treated at each dose level. The objective of this study is to define the safety and tolerability of eFT226 as monotherapy, determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for eFT226 as monotherapy, to evaluate the PK profile of eFT226, and to evaluate preliminary antitumor activity of eFT226 as monotherapy in subjects with defined, advanced solid tumors.