Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
Recruiting now · Phase 1/Phase 2
Conditions studied: HER2 Expressing Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT07192432
- Run by
- Vironexis Biotherapeutics Inc.
- People needed
- 27
- Starts
- 2025-11-18
- Expected to finish
- 2033-10-01
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
- SCRI Denver DDU at HealthOne — Denver, Colorado, United States (enrolling)
- Mayo Clinic — Jacksonville, Florida, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Hackensack Medical Center — Hackensack, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- UT MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- VCU Massey CTO Phase I Solid Team — Richmond, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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