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Gene Therapy for HER-Positive Cancer (SENTRY-HER2)

NCT07192432

RecruitingPhase 1, Phase 2

Sponsor: Vironexis Biotherapeutics Inc.

Conditions: HER2 Expressing Solid Tumors

Interventions: Dose Level 1, VNX-202, Dose Level 2, VNX-202, Dose Level 3, VNX-202, Dose Level 4, VNX-202

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (11)

Los Angeles, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Rochester, Minnesota, United States
Hackensack, New Jersey, United States
New York, New York, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Richmond, Virginia, United States