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Phase 1Recruiting

Gene Therapy for HER-Positive Cancer (SENTRY-HER2)

Sponsored by Vironexis Biotherapeutics Inc.

About this study

This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.

VNX-202 is an investigational adeno-associated virus (AAV) gene therapy developed to express a secreted anti-HER2/anti-CD3 scFv diabody (termed GP202). GP202 binds to human epidermal growth factor receptor 2 (HER2) on the surface of cancer cells and to cluster of differentiation (CD)3 on the surface of T cells, inducing the T cells to kill the HER2-positive cancer cells. Following a single intravenous (IV) infusion, the vector induces the liver to continuously secrete GP202 into the bloodstream, resulting in long-term, consistent serum levels of GP202. Compared with conventionally delivered protein therapies, this gene therapy approach obviates the requirement for episodic dosing and avoids a possible reduction or loss of efficacy associated with trough levels of the protein between treat…

Where this study is enrolling (11)

  • Valkyrie Clinical Trials

    Los Angeles, California

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  • SCRI Denver DDU at HealthOne

    Denver, Colorado

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  • Mayo Clinic

    Jacksonville, Florida

    Call 855-776-0015

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  • Mayo Clinic

    Rochester, Minnesota

    Call 855-776-0015

    This research site can be reached directly by phone. Call to ask about this study.

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  • Hackensack Medical Center

    Hackensack, New Jersey

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Who can participate

Inclusion criteria

  • ✓Age: ≥18 years of age
  • ✓Histologically or cytologically confirmed diagnosis of HER-2 positive solid tumor as defined in the protocol
  • ✓Part 1: presence of advanced or metastatic disease that has progressed during or following previous treatment
  • ✓Part 2: Early stage HER-2 positive cancers with high risk for relapse following completion of SOC or after neoadjuvant systemic treatment
  • ✓AAV specified capsid total antibody ≤1:400
  • ✓ECOG performance status of 0 or 1
  • ✓Life expectancy ≥3 months
  • ✓Protocol-specified ranges for renal, liver, cardiac and pulmonary function
  • ✓Protocol-specified ranges for hematology parameters

Exclusion criteria

  • ✕Hepatoxicity (AST or ALT \> 2x upper limit of normal)
  • ✕Known active CNS or leptomeningeal disease
  • ✕History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy
  • ✕Pregnant or nursing (lactating) women
  • ✕History of other malignancy within 5 years prior to screening as defined in protocol
  • ✕History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity Concurrent anti-cancer treatment in another investigational trial

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.