Clinical trial · Interventional
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
A Phase 1/2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer
NCT07192432CI-TRIAL-00119564SENTRY-HER2recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Expressing Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose Level 1, VNX-202 | Genetic | — | UNRESOLVED |
| Dose Level 2, VNX-202 | Genetic | — | UNRESOLVED |
| Dose Level 3, VNX-202 | Genetic | — | UNRESOLVED |
| Dose Level 4, VNX-202 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Group 1/Group 2/Group 3/Group 4
- interventionNames
- Genetic: Dose Level 1, VNX-202
- Genetic: Dose Level 2, VNX-202
- Genetic: Dose Level 3, VNX-202
- Genetic: Dose Level 4, VNX-202
Primary outcomes (1)
- measure
- Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
- timeFrame
- Change from Baseline to Year 5 post dosing
Secondary outcomes (4)
- measure
- Change from baseline in T cell subsets and clonality
- timeFrame
- Change from baseline to year 5 post dosing
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.