61 Participants Needed

VK-2019 for Nasopharyngeal Cancer

EW
Overseen ByElizabeth Winters
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing VK 2019, a new cancer treatment, on patients with a specific type of throat cancer linked to the Epstein-Barr virus who have no other treatment options. The goal is to see if VK 2019 can effectively fight the cancer and to understand its safety and effects on patients.

Will I have to stop taking my current medications?

The trial requires that you do not take any other systemic cancer treatments, including complementary or alternative therapies, while participating. It does not specify about other medications, so you should discuss your current medications with the trial team.

What safety data exists for VK-2019 in humans?

VK-2019 is currently in phase 1 development, which means it is being tested for safety in humans, but specific safety data from these trials is not provided in the available research articles.12345

How does the drug VK-2019 work differently from other treatments for nasopharyngeal cancer?

VK-2019 is unique because it specifically targets and inhibits EBNA1, a protein crucial for the Epstein-Barr virus (EBV) that is associated with nasopharyngeal cancer. This targeted approach is different from other treatments that may not specifically address the EBV component of the cancer.13456

What data supports the effectiveness of the drug VK-2019 for treating nasopharyngeal cancer?

Research shows that VK-2019 is a specific inhibitor of EBNA1, a protein critical for the maintenance of the Epstein-Barr virus in cancer cells. Similar EBNA1 inhibitors have shown strong anti-cancer effects in models of other Epstein-Barr virus-associated cancers, suggesting potential effectiveness for nasopharyngeal cancer.12378

Who Is on the Research Team?

AD

A. Dimitrios Colevas

Principal Investigator

Stanford Universiy

Are You a Good Fit for This Trial?

Adults with EBV-positive nasopharyngeal cancer not eligible for standard treatments can join. They must have good kidney function, controlled protein in urine, agree to birth control use, and be generally well enough (ECOG ≤2). Prior treatments should be completed with recovered side effects (except stable chronic issues), and blood counts need to meet specific levels.

Inclusion Criteria

Platelet count > 75 x 103/ µL (transfusion to achieve this level is NOT permitted)
My white blood cell count is healthy without medication.
My urine protein levels are low, under 1g/24 hours if tested with a 24-hour collection.
See 13 more

Exclusion Criteria

Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the subject inappropriate for entry into the study
I am not pregnant, confirmed by a test.
I am HIV positive but have a stable condition with effective treatment, no opportunistic infections, a CD4 count above 250, and an undetectable viral load.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VK 2019 in cycles of 28 days, up to 12 cycles, until progression or dose limiting toxicity

12 months
Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Extension

Participants may continue to be monitored for overall survival and progression-free survival

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • VK-2019
Trial Overview The trial is testing VK-2019's effectiveness against EBV-related nasopharyngeal carcinoma when no other treatment options are available. It includes pharmacokinetic and pharmacodynamic studies to understand how the drug behaves in the body and its biological effects.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: VK-2019_armExperimental Treatment1 Intervention
Dose escalation and expansion up to 31 additional patients at a maximum of 1800 mg twice daily. Cycles will be defined as 28 days of treatment, subjects will receive VK 2019 until progression or dose limiting toxicity, for up to 12 cycles.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Silencing the Epstein-Barr virus nuclear antigen 1 (EBNA1) in nasopharyngeal carcinoma (NPC) cells significantly inhibited their growth and induced a G1-phase cell cycle arrest, suggesting a potential therapeutic target for NPC.
The study demonstrated that down-regulation of EBNA1 led to decreased levels of key cell cycle regulators (c-myc, CDK4, CDK6, and pRb), which are crucial for cell proliferation, indicating a mechanism by which EBNA1 promotes cancer cell growth.
[Effect of Epstein-Barr virus nuclear antigen 1 on cell proliferation and cell cycle in nasopharyngeal carcinoma cells].Wan, RQ., Li, XP., Wang, L., et al.[2019]
VK-2019 is a specific inhibitor of the EBNA1 protein from the Epstein Barr virus, which is crucial for the replication of EBV in cancer cells, and is currently being tested in phase 1 trials for treating EBV-associated cancers.
A reliable method for measuring VK-2019 levels in human plasma was developed, showing that the drug is stable for up to 18 months at -70°C, which is important for understanding its pharmacokinetics in patients.
Validation of a robust and rapid liquid chromatography tandem mass spectrometric method for the quantitative analysis of VK-2019, a selective EBNA1 inhibitor.Davis, MT., Anders, NM., Colevas, AD., et al.[2023]
The meta-analysis of 21 studies involving 2986 nasopharyngeal carcinoma (NPC) patients and 3507 controls found that serum VCA-IgA has a high diagnostic accuracy for NPC, with a sensitivity of 83% and specificity of 88%.
Combining multiple EBV antigens for testing significantly improved diagnostic performance, achieving a sensitivity of 93% and specificity of 95%, suggesting that using a panel of tests may be more effective than relying solely on the VCA-IgA assay.
Diagnostic Value of Serum Epstein-Barr Virus Capsid Antigen-IgA for Nasopharyngeal Carcinoma: a Meta-Analysis Based on 21 Studies.Chen, Y., Xin, X., Cui, Z., et al.[2019]

Citations

[Effect of Epstein-Barr virus nuclear antigen 1 on cell proliferation and cell cycle in nasopharyngeal carcinoma cells]. [2019]
Validation of a robust and rapid liquid chromatography tandem mass spectrometric method for the quantitative analysis of VK-2019, a selective EBNA1 inhibitor. [2023]
Diagnostic Value of Serum Epstein-Barr Virus Capsid Antigen-IgA for Nasopharyngeal Carcinoma: a Meta-Analysis Based on 21 Studies. [2019]
EBNA1 inhibitors have potent and selective antitumor activity in xenograft models of Epstein-Barr virus-associated gastric cancer. [2022]
Epstein-Barr virus nuclear antigen 1 (EBNA1) protein induction of epithelial-mesenchymal transition in nasopharyngeal carcinoma cells. [2019]
EBNA-1 sequence variation in Danish and Chinese EBV-associated tumours: evidence for geographical polymorphism but not for tumour-specific subtype restriction. [2022]
Enhanced malignant progression of nasopharyngeal carcinoma cells mediated by the expression of Epstein-Barr nuclear antigen 1 in vivo. [2006]
The sequence analysis of Epstein-Barr virus EBNA1 gene: could viral screening markers for nasopharyngeal carcinoma be identified? [2020]
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