Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Summary

Participation Requirements

Description

Part 1 (dose escalation) will enroll subjects with an 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 ...

Part 1 (dose escalation) will enroll subjects with an 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. Subjects will be assigned sequentially to increasing eFT226 doses. The starting dose of eFT226 is 0.005 mg/kg administered IV weekly in 21 day cycles. 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 in Part 1 will enroll subjects based on 3+3 design, whereby 3 subjects will be initially enrolled and treated at each dose level. To obtain as robust a data set as possible regarding PK, safety and tolerability in a diverse population prior to selecting the RP2D, the MTD and MTD-1 cohorts may be backfilled up to 15 subjects total in each cohort. Part 2 (Expansion Cohort) of the study will provide cohort expansion to further explore the safety, pharmacology, and clinical activity of eFT226 monotherapy in subjects with previously treated advanced solid tumor malignancies. Part 2 will be based on results observed in Part 1 and will be defined by amendment to the protocol.

Tracking Information