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RecruitingPhase 1 / Phase 2

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

A Phase 1/2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests VNX-202, a gene therapy, in adults with HER2-positive cancer. These cancers test positive for a protein called HER2. Researchers will test different doses to learn how safe the treatment is and how well it works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • A tissue or cell test confirms a HER2-positive solid tumor that meets the study rules.
  • For Part 1: Your cancer is advanced or has spread, and it got worse during or after past treatment.
  • For Part 2: Your cancer is early-stage and has a high risk of coming back after standard care or after drug treatment given before surgery.
  • Your antibody level against the specified AAV virus coating is 1:400 or lower. Antibodies are proteins made by your immune system.
  • You can do all your usual activities, or you have limits only with hard physical activity.
  • You are expected to live at least 3 months.
  • Your kidney, liver, heart, lung, and blood tests meet the study's required ranges.

Who can't join

  • Your AST or ALT liver test level is more than twice the upper normal limit.
  • You have known active cancer in the brain, spinal cord, or their lining.
  • You have a history of small blood vessel clots or heart muscle disease, or signs of nerve damage that affects feeling.
  • You are pregnant or breastfeeding.
  • You had another cancer in the past 5 years that falls under the study's exclusion rules.
  • You have had an allergic reaction to corticosteroids or harmful effects from them. These medicines reduce swelling and immune activity.
  • You are receiving cancer treatment in another research study at the same time.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (11)

CA

CO

FL

MN

NJ

NY

OH

PA

TN

TX

VA