A Phase 1-2 Study of Lucicebtide (ST101) in Patients With Advanced Solid Tumors
NCT04478279
Purpose of the Study
Lucicebtide (ST101) is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of Lucicebtide administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
Eligibility
AGE:
18+
SEX:
ALL
Conditions
Newly Diagnosed Glioblastoma (ndGBM) | Recurrent Glioblastoma (rGBM)
Status
Phase 2 Enrollment Complete
Phase
Phase 2
Program Overview
Lucicebtide, a first-in-class antagonist of C/EBPβ, is currently being evaluated in patients with newly diagnosed and recurrent GBM (ndGBM and rGBM) in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279). In an ongoing window-of-opportunity sub-study, lucicebtide is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in ndGBM, with patients receiving lucicebtide before and after surgical resection.
Lucicebtide has been granted Fast Track designation for rGBM from the U.S. FDA and Orphan Drug designations for glioma from the U.S. FDA and the European Commission.