Gene Therapy for HER2 Positive Cancer

(SENTRY-HER2 Trial)

Recruiting at 1 trial location

Overseen By Allen Reha

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Vironexis Biotherapeutics Inc.

Disqualifiers: CNS disease, Cardiomyopathy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new gene therapy treatment called VNX-202 for individuals with HER2 positive cancers. These cancers contain a protein called HER2, which accelerates their growth. The trial will assess the treatment's effectiveness in patients with advanced or metastatic disease and those at high risk for relapse after standard treatments. Individuals with a confirmed HER2 positive solid tumor, whose cancer has progressed, and who are not currently participating in another trial might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot be on another investigational anti-cancer treatment at the same time.

Is there any evidence suggesting that VNX-202 is likely to be safe for humans?

Research has shown that VNX-202 is undergoing its first human trials to assess safety. This early trial evaluates how well participants tolerate the treatment and identifies any side effects. As a combination of Phase 1 and Phase 2 trials, safety information is still being collected and analyzed.

Currently, detailed information on patient responses to VNX-202 is unavailable, so specific data on side effects or adverse reactions is not yet known. Participants in early trials like this receive close monitoring to ensure their safety, with adjustments made as necessary.

Prospective participants should discuss any concerns with the trial organizers or their doctor. They can provide more information based on the latest research and what is best for individual health. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about VNX-202 for HER2 positive cancer because it represents a novel approach using gene therapy. Unlike standard treatments like trastuzumab or pertuzumab, which are monoclonal antibodies targeting the HER2 protein, VNX-202 aims to modify the DNA within cancer cells to inhibit their growth directly. This innovative mechanism could potentially offer more long-lasting effects and reduced side effects compared to traditional therapies, by directly altering the genetic makeup of the cancer cells. By targeting the disease at its genetic roots, VNX-202 might provide a powerful new option for patients with HER2 positive cancer.

What evidence suggests that VNX-202 might be an effective treatment for HER2 positive cancer?

A previous study showed that patients with HER2-positive cancers responded well to gene therapies targeting this cancer type, slowing or stopping cancer cell growth. In this trial, participants will receive VNX-202, which aims to target HER2-positive cancer cells directly using a similar method. Although VNX-202 is a new treatment with limited data from human studies, early results from gene therapies in general suggest it could be effective. Researchers hope VNX-202 can provide a new way to treat these cancers by directly altering the genes involved in cancer growth. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults over 18 with HER-2 positive solid tumors that have worsened after treatment can join this trial. They should be in good physical condition, with a life expectancy of at least 3 months and normal organ function. Those with early-stage high-risk cancers post-treatment may also qualify.

Inclusion Criteria

My advanced cancer has worsened despite treatment.

My early stage HER-2 positive cancer has a high risk of returning after standard treatment.

I can carry out all my usual activities without help.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-finding (Part 1)

Dose-finding PK study to determine the minimal dose that achieves target PK serum levels of GP202 at steady state without dose-limited toxicities

8 weeks

Dose Expansion (Part 2)

Determine the safety and pharmacokinetics (PK) of VNX-202 at the RP2D in a broader array of subjects

Varies

Follow-up

Participants are monitored for safety and efficacy after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• VNX-202

Trial Overview The SENTRY-HER2 trial is testing VNX-202, a gene therapy for cancer, at different doses to see how safe it is and how well it works. It's an early-phase study where patients receive increasing amounts of the drug to find the best dose.

How Is the Trial Designed?

Group I: Group 1/Group 2/Group 3/Group 4 Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Vironexis Biotherapeutics Inc.

Lead Sponsor

Trials

1

Recruited

30+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07192432

Gene Therapy for HER-Positive Cancer (SENTRY-HER2) 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12116439/

Real-world treatment patterns and outcomes among patients ... This study aimed to describe treatment patterns and outcomes in patients with HER2-positive unresectable or metastatic breast cancer in the real-world setting.

3. oncologynewscentral.com oncologynewscentral.com/slideshow/wave-of-pivotal-data-hits-her2-positive-breast-cancer-care

Wave of Pivotal Data Hits HER2-Positive Breast Cancer Care Long-Term Outcomes ... As of the data cutoff, there was a 17% reduction in the risk for death for patients who were treated with the pertuzumab- ...

4. mskcc.org mskcc.org/news/new-drug-combination-for-er-her2-breast-cancer-may-improve-outcomes

New Drug Combination Improves Survival for ER+, HER2 Learn about a three-drug treatment that has been shown to extend survival for ER+, HER2- breast cancers.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11228398/

Emerging treatments in HER2-positive advanced breast cancer The addition of pertuzumab to trastuzumab and taxane demonstrated a median progression-free survival (PFS) of 18.7 months in untreated, advanced HER2-positive ...

6. synapse.patsnap.com synapse.patsnap.com/drug/460911343aa542c58b9c97993b6ba42b

VNX-202 - Drug Targets, Indications, Patents A Phase 1/2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer. 100 Clinical Results associated with VNX-202.

7. withpower.com withpower.com/trial/phase-2-her2-expressing-solid-tumours-10-2025-69487

Gene Therapy for 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 ...

8. bioworld.com bioworld.com/articles/712505-vironexis-exits-stealth-with-10-aav-delivered-immuno-oncology-candidates

Vironexis exits stealth with 10+ AAV-delivered immuno- ... The company is in pre-IND talks with the FDA for a second program, VNX-202, which targets HER2-positive tumors. Varma said he expects that ...

9. cbinsights.com cbinsights.com/company/vironexis

Vironexis - Products, Competitors, Financials, Employees ... Vironexis is a biotechnology company focused on pioneering adeno-associated viruses (AAV)-delivered T-cell immuno-gene therapy for cancer treatment.