Study on a New Drug, VK 2019, for Patients with Epstein Barr Virus-Positive Nasopharyngeal Cancer and Other Related Cancers

Sponsor: Stanford University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04925544

Provider View

This clinical trial is testing a new drug, VK 2019, to see if it can help treat nasopharyngeal cancer and other cancers linked to the Epstein Barr Virus (EBV) when no other standard treatments are available.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of a new drug, VK 2019, in treating cancers associated with the Epstein Barr Virus (EBV), such as nasopharyngeal carcinoma (NPC), especially for patients who have no other standard treatment options. The study will also look at the safety of the drug and its effects on survival and other health markers.

Description

The main goal of this study is to see how well VK 2019 works against tumors in patients with EBV-related cancers. Researchers will also study the safety of the drug, how long patients survive, and how the drug behaves in the body. Additionally, the study will explore the drug's effects on patients with post-transplant lymphoproliferative disorder (PTLD) and EBV-related lymphoma.

Participants must meet certain criteria to join the study, such as having EBV-positive nasopharyngeal cancer that cannot be cured with current treatments. They must also be in good health overall, with specific blood counts and organ functions within normal ranges. Participants will need to agree to use birth control during the study and for a period after the last dose of VK 2019. The study will involve regular health checks and monitoring to ensure the safety and effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent before any study procedures.
  • Have EBV-positive nasopharyngeal cancer that has returned or spread and cannot be cured with current treatments.
  • Not eligible for other approved or standard therapies.
  • Completed any prior radiation therapy at least 2 weeks before starting the study.
  • Finished any previous cancer treatments more than 4 weeks before the first dose of VK 2019 and recovered from any side effects.
  • Be 18 years or older.
  • Have specific blood counts and organ functions within normal ranges.
  • Agree to use birth control during the study and for 18 weeks after the last dose.
  • Have a performance status score of 2 or less, indicating the ability to carry out daily activities.
  • Be able to understand and sign the consent form.

Exclusion Criteria

  • Cannot be receiving other cancer treatments, including alternative or herbal therapies.
  • Cannot have severe heart or lung diseases or recent hospitalizations for respiratory illnesses.
  • Cannot have active cancer in the brain, but stable brain metastases after treatment are allowed.
  • Cannot have uncontrolled medical conditions or active infections.
  • Cannot have a history of organ or bone marrow transplants.
  • Cannot have drug or alcohol dependence.
  • Women cannot be pregnant or breastfeeding and must have a negative pregnancy test before joining.
  • Cannot have other severe medical or psychiatric conditions that could interfere with the study.

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