RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- Age: ≥18 years of age
- diagnosed by tissue sample (biopsy-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
- You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1
- Life expectancy ≥3 months
- Protocol-specified ranges for renal, liver, cardiac and pulmonary function
- Protocol-specified ranges for hematology parameters
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
GENETIC
Dose Level 1, VNX-202
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
GENETIC
Dose Level 2, VNX-202
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
GENETIC
Dose Level 3, VNX-202
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
GENETIC
Dose Level 4, VNX-202
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Locations (4)
Valkyrie Clinical Trials
Los Angeles, California, United States
SCRI Denver DDU at HealthOne
Denver, Colorado, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States