VNX-202 gene therapy for HER2-positive solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human Phase 1/2, open-label, dose-escalation and expansion study of VNX-202, an AAV vector designed to drive continuous systemic secretion of a secreted anti-HER2/anti-CD3 diabody called GP202. Part 1 (about 12 patients) uses escalating single IV doses to find the minimal dose that achieves target steady-state PK levels at 8 weeks without dose-limiting toxicities and to define the recommended Part 2 dose. Part 2 (about 15 patients) will enroll patients with earlier-stage, high relapse–risk HER2-positive disease to characterize safety and preliminary anti-tumor activity at the selected dose. Safety monitoring includes standard labs, hepatic assessments, and long-term follow-up for AAV-related events and immune-mediated toxicities.

Why it matters

Who can join: the full rules

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

Where it's running

• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting
• SCRI Denver DDU at HealthOne
  Denver, Colorado, United States Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Hackensack Medical Center
  Hackensack, New Jersey, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Allen Reha
• Email: allen.reha@vironexis.com
• Phone: 908-938-6019

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining SHR-A1811 with other treatments for advanced solid tumors

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• VRN101099 for HER2-positive solid tumors

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• Evaluating IAM1363 for HER2-related cancers

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.