NCT07192432RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 17 Sept 2025
- Start date
- 18 Nov 2025
- Primary completion date
- Sept 2033
- Lead sponsor
- Vironexis Biotherapeutics Inc.
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07192432
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 27
- From 18 Nov 2025 to the primary completion date, Sept 2033
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity Concurrent anti-cancer treatment in another investigational trial
Other illness
- Known active CNS or leptomeningeal disease
- History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy
- History of other malignancy within 5 years prior to screening as defined in protocol
Lab values
- Hepatoxicity (AST or ALT \> 2x upper limit of normal)
Other
- Pregnant or nursing (lactating) women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| SCRI Denver DDU at HealthOne Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Hackensack Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| UT MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Valkyrie Clinical Trials Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| VCU Massey CTO Phase I Solid Team Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.