Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of
malignant primary brain tumor in adults and can be resistant to conventional therapies.
The purpose of this Phase Ib study is to evaluate how well a recurrent glioblastoma or
gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified,
conditionally replicative and oncolytic human-derived adenovirus. DNX-2401 is delivered
directly into the tumor where it may establish an active infection by replicating in and
killing tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02197169.
Enrollment has been completed for the randomized portion of the study with ongoing
evaluation of tumor response and safety. No additional subjects will be randomized or
receive interferon gamma (IFN-γ).
The non-randomized portion of the study is open for screening and enrollment. Eligible
subjects will receive a single intratumoral injection of DNX-2401 into a recurrent
glioblastoma or gliosarcoma brain tumor using the Alcyone MEMS Cannula (AMC™) System
(cannula). Tumor response and safety will be evaluated.
After receiving DNX-2401, subjects will return to the clinic for study visits at regular
intervals for safety monitoring, MRI scans and other assessments for up to 18 months.
Thereafter, they will be followed closely for safety and survival.
Lead OrganizationDNAtrix, Inc.
