Recruiting

Phase 1

Phase 2

VNX-202Gene Therapy for HER-Positive Cancer (SENTRY-HER2)

Sponsor:

Vironexis Biotherapeutics Inc.

Code:

NCT07192432

Conditions

HER2 Expressing Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dose Level 1, VNX-202

Dose Level 2, VNX-202

Dose Level 3, VNX-202

Dose Level 4, VNX-202

Study Details

Brief summary:

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.

Conditions

HER2 Expressing Solid Tumors

Study ID

NCT07192432

Start date

Nov 18, 2025

Status verified date

Jul, 2026

Completion date

Oct, 2033

Anticipated

Primary completion date

Sep, 2033

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1/Group 2/Group 3/Group 4

Interventions

Dose Level 1, VNX-202

Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion

Dose Level 2, VNX-202

Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion

Dose Level 3, VNX-202

Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion

Dose Level 4, VNX-202

Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion

Primary outcome measure

Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) [ Time Frame: Change from Baseline to Year 5 post dosing ]

Central Contacts and Locations

Central contacts

Allen Reha

908-938-6019 allen.reha@vironexis.com

Locations

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Contacts

Myo Zaw

424-535-1874 clinicaltrials@vctcare.com

SCRI Denver DDU at HealthOne

Recruiting

Denver, Colorado, United States, 80218

Contacts

Julia Etchart

805-701-0185 julia.etchart@sarahcannon.com

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

855-776-0015

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55095

Contacts

855-776-0015

Hackensack Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

551-996-1777 OncologyResearchReferral@hmhn.org

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Jamie Walters

917-843-7966 waltersj@mskcc.org

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

866-223-8100 canceranswer@ccf.org

Thomas Jefferson University, Sidney Kimmel Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Steven Manobianco, MD

215-955-8874 steven.manobianco@jefferson.edu

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

SCRI Referrals

615-329-7274 SCRI.DDUreferrals@scri.com

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Christine Tran

713-794-1354 cmtran@mdanderson.org

VCU Massey CTO Phase I Solid Team

Recruiting

Richmond, Virginia, United States, 23298

Contacts

804-628-6430 masseysiit@vcu.edu

More Information

Sponsor

Vironexis Biotherapeutics Inc.

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

HER2+ breast cancer
HER2+ gastric cancer
Other HER+ cancer
HER2-low cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vironexis Biotherapeutics Inc. on 2026-07-28.