Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
Recruiting · NCT07192432 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Dose Level 1, VNX-202Dose Level 2, VNX-202Dose Level 3, VNX-202Dose Level 4, VNX-202
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
11 locations listed across 11 US states.
- Valkyrie Clinical Trials - Los Angeles, California, United States
- SCRI Denver DDU at HealthOne - Denver, Colorado, United States
- Mayo Clinic - Jacksonville, Florida, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Hackensack Medical Center - Hackensack, New Jersey, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Thomas Jefferson University, Sidney Kimmel Cancer Center - Philadelphia, Pennsylvania, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- UT MD Anderson Cancer Center - Houston, Texas, United States
- VCU Massey CTO Phase I Solid Team - Richmond, Virginia, United States