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
Qualifiers
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
Treatments tested in this trial
- Dose Level 1, VNX-202
- Dose Level 2, VNX-202
- Dose Level 3, VNX-202
- Dose Level 4, VNX-202
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov