HER2 Expressing Solid TumorsPhase 1/2SENTRY-HER2NCT07192432
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
A Phase 1/2 study testing Dose Level 1, VNX-202, Dose Level 2, VNX-202 and Dose Level 3, VNX-202 in people with HER2 Expressing Solid Tumors, run by Vironexis Biotherapeutics Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 Expressing Solid Tumors
- What is being tested?
- Dose Level 1, VNX-202, Dose Level 2, VNX-202 and Dose Level 3, VNX-202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 11 sitesUnited States
- Study dates
- 18 Nov 2025to Oct 2033
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Life expectancy ≥3 months
- Protocol-specified ranges for renal, liver, cardiac and pulmonary function
- Protocol-specified ranges for hematology parameters
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
866-223-8100, canceranswer@ccf.org
- Recruiting
SCRI Denver DDU at HealthOne
Denver, Colorado, 80218
Julia Etchart, 805-701-0185, julia.etchart@sarahcannon.com
- Recruiting
Hackensack Medical Center
Hackensack, New Jersey, 07601
551-996-1777, OncologyResearchReferral@hmhn.org
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Christine Tran, 713-794-1354, cmtran@mdanderson.org
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
855-776-0015
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
Myo Zaw, 424-535-1874, clinicaltrials@vctcare.com
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
SCRI Referrals, 615-329-7274, SCRI.DDUreferrals@scri.com
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Jamie Walters, 917-843-7966, waltersj@mskcc.org
- Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Steven Manobianco, MD, 215-955-8874, steven.manobianco@jefferson.edu
- Recruiting
VCU Massey CTO Phase I Solid Team
Richmond, Virginia, 23298
804-628-6430, masseysiit@vcu.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55095
855-776-0015
About this study
Official title: A Phase 1/2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer
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.
Read the detailed description
VNX-202 is an investigational adeno-associated virus (AAV) gene therapy developed to express a secreted anti-HER2/anti-CD3 scFv diabody (termed GP202). GP202 binds to human epidermal growth factor receptor 2 (HER2) on the surface of cancer cells and to cluster of differentiation (CD)3 on the surface of T cells, inducing the T cells to kill the HER2-positive cancer cells.
Following a single intravenous (IV) infusion, the vector induces the liver to continuously secrete GP202 into the bloodstream, resulting in long-term, consistent serum levels of GP202. Compared with conventionally delivered protein therapies, this gene therapy approach obviates the requirement for episodic dosing and avoids a possible reduction or loss of efficacy associated with trough levels of the protein between treatment cycles.
In this 2-part study, dose-finding data from Part 1 of the study (n=~12 patients) will be used determine the dose for Part 2 in patients. Part 1 is a dose-finding PK study in adults ≥18 years old with previously treated metastatic HER2 solid tumors designed to determine the minimal dose that achieves target PK serum levels of GP202 at steady state (8-week timepoint) without dose-limited toxicities, defined as the recommended Part 2 dose (RP2D). Participants must have histologically or cytologically confirmed HER2 positive solid tumor cancers that has progressed during or following previous anti-cancer treatment. Part 2 (n=~15) will be opened following data safety monitoring board review of Part 1 data and is designed to determine the safety and pharmacokinetics (PK) of VNX-202 at the RP2D in a broader array of subjects. Part 2 will comprise of participants with early stage HER2-positive tumors who are at risk of disease relapse and/or metastasis despite having received prior systemic and/or local treatment. Each cohort will comprise ≥5 participants (Cohort A: breast cancer; Cohort B: gastric cancer; Cohort C: all otherHER2-positive tumor types). Patients will be followed for safety and efficacy up to 5 years post VNX-202 dosing.
- Conditions
- HER2 Expressing Solid Tumors
- Being tested
- Dose Level 1, VNX-202, Dose Level 2, VNX-202, Dose Level 3, VNX-202, Dose Level 4, VNX-202
- Keywords
- HER2+ breast cancer, HER2+ gastric cancer, Other HER+ cancer, HER2-low cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Group 1/Group 2/Group 3/Group 4 | Experimental | Not described Receives: Genetic: Dose Level 1, VNX-202; Genetic: Dose Level 2, VNX-202; Genetic: Dose Level 3, VNX-202; Genetic: Dose Level 4, VNX-202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Measured: Change from Baseline to Year 5 post dosing
Secondary outcomes (4)
Change from baseline in T cell subsets and clonality
Measured: Change from baseline to year 5 post dosing
Change from baseline in ctDNA
Measured: Change from baseline to year 5 post dosing
Change from baseline in progression free survival
Measured: Change from baseline to year 5 post dosing
Change from baseline in overall survival
Measured: Change from baseline to year 5 post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start18 Nov 2025
- Primary completionSep 2033 (estimated)
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Expressing Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vironexis Biotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192432
- Sponsor's protocol ID
- VNX-202-01
- Acronym
- SENTRY-HER2
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer
- ClinicalTrials.gov ID
- NCT07192432
- Acronym / sponsor ID
- SENTRY-HER2 / VNX-202-01
- Conditions
- HER2 Expressing Solid Tumors
- Keywords
- HER2+ breast cancer, HER2+ gastric cancer, Other HER+ cancer, HER2-low cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Vironexis Biotherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- Sep 2033 (estimated)
- Study completion
- Oct 2033 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
VNX-202 is an investigational adeno-associated virus (AAV) gene therapy developed to express a secreted anti-HER2/anti-CD3 scFv diabody (termed GP202). GP202 binds to human epidermal growth factor receptor 2 (HER2) on the surface of cancer cells and to cluster of differentiation (CD)3 on the surface of T cells, inducing the T cells to kill the HER2-positive cancer cells.
Following a single intravenous (IV) infusion, the vector induces the liver to continuously secrete GP202 into the bloodstream, resulting in long-term, consistent serum levels of GP202. Compared with conventionally delivered protein therapies, this gene therapy approach obviates the requirement for episodic dosing and avoids a possible reduction or loss of efficacy associated with trough levels of the protein between treatment cycles.
In this 2-part study, dose-finding data from Part 1 of the study (n=~12 patients) will be used determine the dose for Part 2 in patients. Part 1 is a dose-finding PK study in adults ≥18 years old with previously treated metastatic HER2 solid tumors designed to determine the minimal dose that achieves target PK serum levels of GP202 at steady state (8-week timepoint) without dose-limited toxicities, defined as the recommended Part 2 dose (RP2D). Participants must have histologically or cytologically confirmed HER2 positive solid tumor cancers that has progressed during or following previous anti-cancer treatment. Part 2 (n=~15) will be opened following data safety monitoring board review of Part 1 data and is designed to determine the safety and pharmacokinetics (PK) of VNX-202 at the RP2D in a broader array of subjects. Part 2 will comprise of participants with early stage HER2-positive tumors who are at risk of disease relapse and/or metastasis despite having received prior systemic and/or local treatment. Each cohort will comprise ≥5 participants (Cohort A: breast cancer; Cohort B: gastric cancer; Cohort C: all otherHER2-positive tumor types). Patients will be followed for safety and efficacy up to 5 years post VNX-202 dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1/Group 2/Group 3/Group 4 | Experimental | Genetic: Dose Level 1, VNX-202, Genetic: Dose Level 2, VNX-202, Genetic: Dose Level 3, VNX-202, Genetic: Dose Level 4, VNX-202 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose Level 1, VNX-202Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion | Genetic | Group 1/Group 2/Group 3/Group 4 |
| Dose Level 2, VNX-202Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion | Genetic | Group 1/Group 2/Group 3/Group 4 |
| Dose Level 3, VNX-202Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion | Genetic | Group 1/Group 2/Group 3/Group 4 |
| Dose Level 4, VNX-202Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion | Genetic | Group 1/Group 2/Group 3/Group 4 |
Primary outcome
Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Time frame: Change from Baseline to Year 5 post dosing
4 secondary outcomes
Change from baseline in T cell subsets and clonality
Time frame: Change from baseline to year 5 post dosing
Change from baseline in ctDNA
Time frame: Change from baseline to year 5 post dosing
Change from baseline in progression free survival
Time frame: Change from baseline to year 5 post dosing
Change from baseline in overall survival
Time frame: Change from baseline to year 5 post dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dose Level 1, VNX-202, Dose Level 2, VNX-202 and Dose Level 3, VNX-202 in people with HER2 Expressing Solid Tumors, run by Vironexis Biotherapeutics Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allen Reha (908-938-6019, allen.reha@vironexis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.