Actively Recruiting
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
Led by Vironexis Biotherapeutics Inc. · Updated on 2026-05-08
27
Participants Needed
5
Research Sites
410 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically or cytologically confirmed HER2 positive solid tumor
- Part 1: Advanced or metastatic HER2 positive disease progressing after previous treatment
- Part 2: Early stage HER2 positive cancer at high risk of relapse after prior treatment
- AAV capsid total antibody level of 1:400 or less
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Acceptable kidney, liver, heart, and lung function as specified in the protocol
- Hematology parameters within protocol-specified ranges
You will not qualify if you...
- Liver toxicity with AST or ALT levels greater than twice the upper limit of normal
- Known active central nervous system or leptomeningeal disease
- History of thrombotic microangiopathy, cardiomyopathy, or sensory neuropathy
- Pregnant or nursing women
- History of another cancer within 5 years prior to screening
- History of hypersensitivity or toxicity related to corticosteroids
- Receiving anti-cancer treatment in another investigational trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
2
SCRI Denver DDU at HealthOne
Denver, Colorado, United States, 80218
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
5
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
A
Allen Reha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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