Clinical Trials /

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

NCT02923466

Description:

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, pheochromocytoma and neuroendocrine tumor (NET) patients . 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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Patients With Refractory Solid Tumors
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: VYR-VSV2-101
  • NCT ID: NCT02923466

Conditions

  • Malignant Solid Tumour

Interventions

DrugSynonymsArms
VSV-IFNβ-NISVSV-IFNβ-NIS
VSV-IFNβ-NIS and avelumabVSV-IFNβ-NIS and avelumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
VSV-IFNβ-NISExperimentalVSV-IFNβ-NIS will be administered intratumorally as a single dose on day 1.
  • VSV-IFNβ-NIS
Selection of VSV-IFNβ-NIS MonotherapyExperimentalVSV-IFNβ-NIS will be administered either intratumorally, intravenously or with a combination of intratumorally and intravenously as a single dose on day 1.
  • VSV-IFNβ-NIS
VSV-IFNβ-NIS and avelumabExperimentalVSV-IFNβ-NIS will be administered as determined in arm 2 as a single dose on day 1. Avelumab will be administered intravenously every 2 weeks starting on day 1.
  • VSV-IFNβ-NIS and avelumab

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) of VSV-IFNβ-NIS Monotherapy and Combination Therapy
Time Frame:21 days after VSV-IFNβ-NIS Monotherapy or Combination Therapy for each dose cohort
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Vyriad, Inc.

Trial Keywords

  • refractory solid tumor

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