Status:
RECRUITING
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
Lead Sponsor:
Vironexis Biotherapeutics Inc.
Conditions:
HER2 Expressing Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2033
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT07192432
Start Date
November 1 2025
End Date
October 1 2033
Last Update
October 10 2025
Active Locations (2)
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1
SCRI Denver DDU at HealthOne
Denver, Colorado, United States, 80218
2
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203