MC# 17-04 - Phase I/II Trial of Intratumoral Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon Beta (VSV-IFNb-NIS), Monotherapy and in Combination With Avelumab in Patients with Refractory Solid Tumors
Agent(s): VSV-IFNb-NIS, Avelumab
Disease Type(s): Bladder, Breast, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatocellular, Lung-NSCLC, Lung-SCLC, Lymphoma, Melanoma, Mesothelioma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Solid Tumor, Squamous Cell, Thyroid, Cholangiocarcinoma
Phase(s): I, II
Drug Classification(s): Viral Therapy
Mechanism of Action
VSV-IFNβ-NIS is a live virus, DNA-engineered to express both the hIFNβ gene and the thyroidal sodium iodide symporter (NIS). It propagates selectively in human cancer cells since many of them (as opposed to normal cells) cannot mount an effective antiviral response mediated via the IFN pathway. As a result, the virus is directly cytopathic to tumor cells, leading to rapid lysis with amplification of the virus. Radioiodine uptake by cells expressing NIS also provides the basis for in vivo imaging with 99mTc pertechnetate or radioiodine I-123.
In this study, the sponsor and investigators want to learn:
- How much VSV-IFNb-NIS can be given with an acceptable level of side effects
- The effects of VSV-IFNb-NIS
- How much VSV-IFNb-NIS is absorbed into the blood and how fast it is removed
- If VSV-IFNβ-NIS prevents or delays tumor growth or shrinks an existing tumor
- How proteins that indicate the status of disease are affected with use of VSV-IFNb-NIS
- Determine what happens to the virus in the body (where it is, how long it stays there, how it multiplies) using 99m-Technetium (99m-Tc) SPECT imaging.
- 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.
- 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.
- Dallas, TX - Mary Crowley Cancer Research - Medical City