This is a three-part open label phase 1 study designed to determine the safety profile,
MTD, PK and tumor and biomarker response after IT or IV administration of a single dose
of VSV-IFNβ-NIS, or combined IT followed by IV VSV-IFNβ-NIS, with or without IV avelumab
every two weeks, in patients with refractory advanced/metastatic solid tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02923466.
The study consists of three parts: a single ascending dose escalation of IT VSV-IFNβ-NIS
monotherapy, a monotherapy IV regimen selection phase and an expansion phase, designed to
explore the safety and efficacy of the chosen monotherapy regimen alone or in combination
with avelumab in patients with metastatic colorectal cancer. Monotherapy will also be
explored in patients with pheochromocytoma and NET.
Patients are required to have at least 1 measurable lesion per RECIST 1.1, and in the
IT-containing arms this lesion should be amenable for a one-time IT injection of
VSV-IFNβ-NIS. At least one patient per IT cohort is required to have at least 2
measurable lesions per RECIST 1.1, one for a one-time IT injection of VSV-IFNβ-NIS and
one to be used as a control. Priority enrollment in the IT-containing arms will be
granted to patients with 2 measurable lesions per RECIST 1.1. At least one patient per
dose level should have metastatic colorectal cancer. In order to fulfil these
requirements, at least 3 or 4 patients will be required per escalation dose cohort. Other
tumor types of particular interest based on prior experience with VSV or oncolytic
viruses include malignant melanoma and endometrial cancer. When more than one cohort is
open simultaneously, slot assignment will be determined by the sponsor in consultation
with the PIs.
Lead OrganizationVyriad, Inc.
