NCT07192432

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
90mo left

Started Nov 2025

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Nov 2025Oct 2033

First Submitted

Initial submission to the registry

September 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 18, 2025

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2033

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2033

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

7.8 years

First QC Date

September 17, 2025

Last Update Submit

March 31, 2026

Conditions

HER2 Expressing Solid Tumors

Keywords

HER2+ breast cancerHER2+ gastric cancerOther HER+ cancerHER2-low cancer

Outcome Measures

Primary Outcomes (1)

  • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)

    Change from Baseline to Year 5 post dosing

Secondary Outcomes (4)

  • Change from baseline in T cell subsets and clonality

    Change from baseline to year 5 post dosing

  • Change from baseline in ctDNA

    Change from baseline to year 5 post dosing

  • Change from baseline in progression free survival

    Change from baseline to year 5 post dosing

  • Change from baseline in overall survival

    Change from baseline to year 5 post dosing

Other Outcomes (2)

  • Change in VNX-202 gene product levels

    Change from baseline to year 5 post dosing

  • Change in VNX-202 vector shedding

    Change from baseline to year 5 post dosing

Study Arms (1)

Group 1/Group 2/Group 3/Group 4

EXPERIMENTAL
Genetic: Dose Level 1, VNX-202Genetic: Dose Level 2, VNX-202Genetic: Dose Level 3, VNX-202Genetic: Dose Level 4, VNX-202

Interventions

Dose Level 2, VNX-202GENETIC

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

Group 1/Group 2/Group 3/Group 4
Dose Level 3, VNX-202GENETIC

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

Group 1/Group 2/Group 3/Group 4
Dose Level 1, VNX-202GENETIC

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

Group 1/Group 2/Group 3/Group 4
Dose Level 4, VNX-202GENETIC

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

Group 1/Group 2/Group 3/Group 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

RECRUITING

SCRI Denver DDU at HealthOne

Denver, Colorado, 80218, United States

RECRUITING

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Central Study Contacts

Allen Reha

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 25, 2025

Study Start

November 18, 2025

Primary Completion (Estimated)

September 1, 2033

Study Completion (Estimated)

October 1, 2033

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)