Recruiting
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
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.
ClinicalTrials.gov IDNCT07192432
PhasePHASE1, PHASE2
Enrollment27
SponsorVironexis Biotherapeutics Inc.
Age18 Years
SexALL
Conditions studied
HER2 Expressing Solid Tumors
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.
Interventions
- Genetic: Dose Level 1, VNX-202 — Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
- Genetic: Dose Level 2, VNX-202 — Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
- Genetic: Dose Level 3, VNX-202 — Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
- Genetic: Dose Level 4, VNX-202 — Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Primary outcomes
- Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) (Change from Baseline to Year 5 post dosing)
Eligibility information
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 locations
- Valkyrie Clinical Trials, Los Angeles, California 90067 United States
- SCRI Denver DDU at HealthOne, Denver, Colorado 80218 United States
- Mayo Clinic, Jacksonville, Florida 32224 United States
- Mayo Clinic, Rochester, Minnesota 55095 United States
- Hackensack Medical Center, Hackensack, New Jersey 07601 United States
- Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States
- Cleveland Clinic, Cleveland, Ohio 44195 United States
- Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania 19107 United States
- SCRI Oncology Partners, Nashville, Tennessee 37203 United States
- UT MD Anderson Cancer Center, Houston, Texas 77030 United States
Showing 10 of 11 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.