Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Patients With Refractory Solid Tumors

Status:	Recruiting
Healthy:	No
Age Range:	18 - Any
Updated:	2/13/2019
Start Date:	April 17, 2017
End Date:	February 2020
Contact:	Barb H Duckett
Email:	bduckett@vyriad.com
Phone:	507-289 0944

Phase 1 Trial of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon Beta (VSV-IFNβ-NIS) Monotherapy and in Combination With Avelumab, in Patients With Refractory Solid Tumors

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. The study consists
of three parts: a single ascending dose escalation of IT VSV-IFNβ-NIS monotherapy, a
monotherapy regimen selection phase (IT alone, IT then IV, or IV alone) 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. This phase
contains a small dose de-escalation-re-escalation period to ensure the safety of the
combination prior to opening the corresponding expansion cohort.

Inclusion Criteria:

- Be > 18 years of age on day of signing informed consent.

- Have a histologically confirmed diagnosis of an advanced and/or metastatic solid tumor
that is relapsed and/or refractory to standard therapy, as defined as progression on
at least one prior line of therapy in the relapsed/metastatic setting and no existing
options are felt to provide clinical benefit.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

- Adequate hematological, liver and kidney function.

- Must be willing to implement contraception throughout study and for 120 days after
receiving the study drug.

Exclusion Criteria:

- Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or
tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of the
start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks of the
start of study treatment; nitrosoureas, antibody-drug conjugates, or radioactive
isotopes within 6 weeks of the start of study treatment.

- Has a history of a bone marrow or solid organ transplant.

- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the pre-screening or screening visit
through 120 days after the last dose of trial treatment.

We found this trial at

sites

University of Miami

Miami, Florida 33124

(305) 284-2211