NCT07192432

A Phase 1/2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer

Study 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.

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Interventions

Dose Level 1, VNX-202GENETIC
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Dose Level 2, VNX-202GENETIC
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Dose Level 3, VNX-202GENETIC
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Dose Level 4, VNX-202GENETIC
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion

Study Locations

FacilityCityStateCountry
Valkyrie Clinical TrialsLos AngelesCaliforniaUnited States
SCRI Denver DDU at HealthOneDenverColoradoUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvaniaUnited States
SCRI Oncology PartnersNashvilleTennesseeUnited States
UT MD Anderson Cancer CenterHoustonTexasUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: May 29, 2026