Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
ConditionHER2 Expressing Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVironexis Biotherapeutics Inc.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Dose Level 1, VNX-202
GeneticAdeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Dose Level 2, VNX-202
GeneticAdeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Dose Level 3, VNX-202
GeneticAdeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Dose Level 4, VNX-202
GeneticAdeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Group 1/Group 2/Group 3/Group 4Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Time frame
Change from Baseline to Year 5 post dosingSecondary outcomes
1
Change from baseline in T cell subsets and clonality
Time frame
Change from baseline to year 5 post dosing2
Change from baseline in ctDNA
Time frame
Change from baseline to year 5 post dosing3
Change from baseline in progression free survival
Time frame
Change from baseline to year 5 post dosing4
Change from baseline in overall survival
Time frame
Change from baseline to year 5 post dosingOther outcomes
1
Change in VNX-202 gene product levels
Time frame
Change from baseline to year 5 post dosing2
Change in VNX-202 vector shedding
Time frame
Change from baseline to year 5 post dosingSponsors and contacts
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Source ClinicalTrials.gov