RECRUITING

Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus (EBV)-Positive Nasopharyngeal Cancer (NPC) and Other Epstein-Barr Virus (EBV)-Associated Cancers, With Pharmacokinetic and Pharmacodynamic Correlative Studies

Conditions

Nasopharyngeal Cancer Epstein-Barr Virus Related Carcinoma Epstein-Barr Virus Nasopharyngeal Carcinoma Nasopharynx cancer VK-2019 NPC EBNA1 inhibitor EBV

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate the anti cancer effect of VK 2019 in subjects with EBV related nasopharyngeal carcinoma (NPC) for whom there is no other standard treatment available

Official Title

Phase 2, Open-label, Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus Positive Nasopharyngeal Cancer (NPC) and Other EBV-associated Cancers, With Pharmacokinetic and Pharmacodynamic Correlative Studies

Quick Facts

Study Start:2022-01-25

Study Completion:2031-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04925544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 1 Informed consent obtained prior to any protocol mandated study specific procedures in accordance with institutional policies. * 2 Either loco regionally recurrent or metastatic EBV positive RECIST evaluable nasopharyngeal carcinoma not amenable to curative treatment with no accepted effective standard of care therapeutic option. * 3 Not eligible for other approved or standard therapies * 4.Prior palliative radiation must have been completed at least 2 weeks prior to study Cycle 1 Day 0 * 5.Prior anti cancer systemic treatment must have been completed greater than 4 weeks prior to the first dose of VK 2019 or subjects must have recovered from all acute prior treatment related AEs * 6.Toxicities related to prior anti cancer therapy must have returned to Grade 1 or less. Peripheral neuropathy must be Grade 2 or less. Chronic but stable toxicities Grade \> 1 (eg, dysphasia, G tube dependence, etc.) are permissible. * 7.Age ≥ 18 * 8.Absolute neutrophil count \> 1500/µL (stable off any growth factor for at least 1 week of study drug administration) * 9.Hemoglobin \> 9g/dL (transfusion to achieve this level is permitted) * 10.Platelet count \> 75 x 103/ µL (transfusion to achieve this level is NOT permitted) * 11.Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) .Total serum bilirubin ≤ 1.5 x ULN * 12.Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min as calculated per Cockcroft Gault equation * 13.Urinary protein \< 2+ by dipstick. If dipstick ≥ 2+, then a 24 hour urine collection can be done and the subject may enter only if urinary protein is \< 1 g/24 hour * 14.Sexually active subjects must agree to utilize birth control method during treatment and for 18 weeks after the last dose of VK 2019. * 15.Eastern Cooperative Oncology Group (ECOG) performance status 2 or less. * 16.Ability to understand and the willingness to personally sign the written IRB approved informed consent document.	* 1.Prior therapy restrictions. * 2.Concurrent treatment with systemic cancer directed therapy including complementary, alternative, herbal or nutritional supplement based treatments whose purpose is for anti cancer effect * 3.Severe or active symptomatic cardiopulmonary diseases, including unstable angina, congestive heart failure, or peripheral vascular disease within 12 months prior to study drug administration; and/or chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 4 weeks prior to study drug administration. Subjects with effectively treated conditions (eg, stenting for coronary artery disease) are eligible if stable for at least 4 weeks prior to study drug administration * 4.Metastatic disease with active central nervous system (CNS) involvement, defined as parenchymal brain involvement. Subjects with cranial nerve or base of skull involvement without the above are eligible. Subjects with CNS metastases that are stable on imaging at least 1 month following focal treatment with radiation are eligible * 5.Known history of human immunodeficiency virus (HIV) unless the HIV positive subjects has: 1. A stable regimen of highly active anti retroviral therapy (HAART) 2. No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections 3. A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR based test * 6.Serious uncontrolled medical disorder or active infection which would, in the opinion of the Investigator, impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy * 7.NPC subjects: Have received a prior organ allograft or allogeneic bone marrow transplant. * 8.Current non prescription drug or alcohol dependence * 9.For all female subjects: pregnancy or breastfeeding * 10.All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment * 11.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 * 12.Corrected QT by Fridericia's formula (QTcF) of \> 470 ms average (mean) on triplicate ECG performed during screening

Inclusion Criteria

Exclusion Criteria

* 1 Informed consent obtained prior to any protocol mandated study specific procedures in accordance with institutional policies.
* 2 Either loco regionally recurrent or metastatic EBV positive RECIST evaluable nasopharyngeal carcinoma not amenable to curative treatment with no accepted effective standard of care therapeutic option.
* 3 Not eligible for other approved or standard therapies
* 4.Prior palliative radiation must have been completed at least 2 weeks prior to study Cycle 1 Day 0
* 5.Prior anti cancer systemic treatment must have been completed greater than 4 weeks prior to the first dose of VK 2019 or subjects must have recovered from all acute prior treatment related AEs
* 6.Toxicities related to prior anti cancer therapy must have returned to Grade 1 or less. Peripheral neuropathy must be Grade 2 or less. Chronic but stable toxicities Grade \> 1 (eg, dysphasia, G tube dependence, etc.) are permissible.
* 7.Age ≥ 18
* 8.Absolute neutrophil count \> 1500/µL (stable off any growth factor for at least 1 week of study drug administration)
* 9.Hemoglobin \> 9g/dL (transfusion to achieve this level is permitted)
* 10.Platelet count \> 75 x 103/ µL (transfusion to achieve this level is NOT permitted)
* 11.Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) .Total serum bilirubin ≤ 1.5 x ULN
* 12.Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min as calculated per Cockcroft Gault equation
* 13.Urinary protein \< 2+ by dipstick. If dipstick ≥ 2+, then a 24 hour urine collection can be done and the subject may enter only if urinary protein is \< 1 g/24 hour
* 14.Sexually active subjects must agree to utilize birth control method during treatment and for 18 weeks after the last dose of VK 2019.
* 15.Eastern Cooperative Oncology Group (ECOG) performance status 2 or less.
* 16.Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

* 1.Prior therapy restrictions.
* 2.Concurrent treatment with systemic cancer directed therapy including complementary, alternative, herbal or nutritional supplement based treatments whose purpose is for anti cancer effect
* 3.Severe or active symptomatic cardiopulmonary diseases, including unstable angina, congestive heart failure, or peripheral vascular disease within 12 months prior to study drug administration; and/or chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 4 weeks prior to study drug administration. Subjects with effectively treated conditions (eg, stenting for coronary artery disease) are eligible if stable for at least 4 weeks prior to study drug administration
* 4.Metastatic disease with active central nervous system (CNS) involvement, defined as parenchymal brain involvement. Subjects with cranial nerve or base of skull involvement without the above are eligible. Subjects with CNS metastases that are stable on imaging at least 1 month following focal treatment with radiation are eligible
* 5.Known history of human immunodeficiency virus (HIV) unless the HIV positive subjects has:
1. A stable regimen of highly active anti retroviral therapy (HAART)
2. No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
3. A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR based test
* 6.Serious uncontrolled medical disorder or active infection which would, in the opinion of the Investigator, impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy
* 7.NPC subjects: Have received a prior organ allograft or allogeneic bone marrow transplant.
* 8.Current non prescription drug or alcohol dependence
* 9.For all female subjects: pregnancy or breastfeeding
* 10.All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment
* 11.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
* 12.Corrected QT by Fridericia's formula (QTcF) of \> 470 ms average (mean) on triplicate ECG performed during screening

Contacts and Locations

Study Contact

Elizabeth Winters

CONTACT

650-723-6372

ewinters@stanford.edu

Principal Investigator

A. Dimitrios Colevas

PRINCIPAL_INVESTIGATOR

Stanford Universiy

Study Locations (Sites)

Stanford University

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

A. Dimitrios Colevas, PRINCIPAL_INVESTIGATOR, Stanford Universiy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-25

Study Completion Date2031-02

Study Record Updates

Study Start Date2022-01-25

Study Completion Date2031-02

Terms related to this study

Keywords Provided by Researchers

Epstein-Barr Virus
Nasopharyngeal Carcinoma
Nasopharynx cancer
VK-2019
NPC
EBNA1 inhibitor
EBV

Additional Relevant MeSH Terms

Nasopharyngeal Cancer
Epstein-Barr Virus Related Carcinoma