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Nasopharyngeal CarcinomaPhase 1/2NCT03682055

Phase 1/2a Study of VK-2019 in Patients With Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (NPC)

A Phase 1/2 study testing VK-2019 in people with Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, run by Cullinan Therapeutics Inc. at 6 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

VK-2019-001 is a 1/2a trial of the oral EBNA-1 targeting agent VK-2019 in patients with EBV-positive recurrent or metastatic NPC to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D), as well as to evaluate the PK profile of VK-2019. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VK-2019
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
6 sitesin 5 countries
Study dates
4 Apr 2019to 8 Aug 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Informed consent obtained prior to any protocol mandated assessment.
  • Age ≥ 18.
  • Either loco regionally recurrent or metastatic EBV positive nasopharyngeal carcinoma not amenable to curative treatment. EBV positivity is defined as high EBV viral load in plasma (> 4000 genomes per µg plasma DNA) and/or biopsy tissue positive for EBV.
  • Prior palliative radiation must have been completed at least 2 weeks prior to study Cycle 1 Day 0.
  • Prior anti cancer systemic treatment must have been completed greater than 4 weeks prior to study Cycle 1 Day 0.
  • 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 (e.g., dysphasia, G tube dependence, etc.) may be allowed after agreement between the Investigator and Sponsor.
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  • For the dose expansion phase only: Patients must have RECIST v1.1 measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non nodal lesions and short axis for nodal lesions) as ≥ 10 mM with spiral CT scan, MRI, or calipers by clinical exam.
  • ECOG performance status score of ≤ 2 at study entry.
  • Absolute neutrophil count > 1500/µL (stable off any growth factor within 1 week of study drug administration).
  • Hemoglobin > 9g/dL (transfusion to achieve this level is permitted).
  • Platelet count > 75 x 103/ µL (transfusion to achieve this level is NOT permitted).
  • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN).
  • Total serum bilirubin ≤ 1.5 x ULN.
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min as calculated per Cockcroft Gault equation.
  • Urinary protein < 2+ by dipstick. If dipstick ≥ 2+, then a 24 hour urine collection can be done and the patient may enter only if urinary protein is < 1 g/24 hour.
  • Sexually active patients must agree to utilize birth control method during the study and for 18 weeks after the study is concluded, using effective birth control methods as defined in https://www.cdc.gov/reproductivehealth/unintendedpregnancy/pdf/contraceptive_methods_508.pdf.
  • Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Who cannot join

  • Severe or active symptomatic cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders; patients with effectively treated conditions (eg, stenting for CAD) are eligible.
  • Metastatic disease with active central nervous system (CNS) involvement, defined as parenchymal brain involvement. Patients with cranial nerve or base of skull involvement without the above are eligible; Patients with CNS metastases stable 1 month following focal treatment with radiation are eligible.
  • Concurrent treatment with systemic cancer directed therapy including complementary, alternative, herbal or nutritional supplement based treatments whose purpose is for anti cancer effect.
  • Positive for human immunodeficiency virus (HIV) are not excluded from this study, but HIV positive patients must have:
  • A stable regimen of highly active anti retroviral therapy (HAART)
  • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
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  • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR based test
  • 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.
  • Currently taking drugs that inhibit or induce OATP1B1 or OATP1B3 within 5 half lives of that agent. Examples are included in Appendix 2.
  • Have received a prior organ allograft or allogeneic bone marrow transplant.
  • Current non prescription drug or alcohol dependence.
  • For all female patients, pregnancy or breastfeeding.
  • All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment.
  • 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 patient inappropriate for entry into the study.
  • Corrected QT by Fridericia's formula (QTcF) of > 470 ms.

Trial locations and contacts

6 sites in 5 countries.

6 sites in 5 countries

United States2 sites

  • The University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • Stanford University, School of Medicine, Stanford Cancer Institute

    Stanford, California, 94305

Other trials in United States

China1 site

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

France1 site

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Hong Kong1 site

  • Hong Kong University - Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

Official title: Phase 1/2a Open Label, Multicenter Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus Positive Nasopharyngeal Cancer, With Pharmacokinetic and Pharmacodynamic Correlative Studies

VK-2019-001 is a 1/2a trial of the oral EBNA-1 targeting agent VK-2019 in patients with EBV-positive recurrent or metastatic NPC to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D), as well as to evaluate the PK profile of VK-2019.

Read the detailed description

This is a Phase 1/2a, open-label, multicenter, first-in-human trial to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of VK-2019 in patients with EBV-positive NPC.

This trial is divided into three parts: Phase 1 Dose Escalation, Phase 1 Dose Expansion, and Phase 2s Dose Expansion.

The objectives of the dose escalation part are to determine the safety, tolerability, MTD, recommended Phase 2 dose (RP2D), and to evaluate the anti-tumor activity of orally administered VK-2019 monotherapy. Additional objectives are to determine the pharmacokinetic (PK) profile of VK-2019.

VK-2019 will be dosed once daily (QD).

Being tested
VK-2019
Keywords
Epstein-Barr Virus, Nasopharyngeal Carcinoma, NPC, EBV, EBNA1 inhibitor, VK-2019, Nasopharynx cancer, Nasopharynx carcinoma
Medical subject headings
Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VK-2019Drug

    EBNA1 inhibitor

Study groups in NCT03682055
Study groupRoleWhat they receive
Phase 1 Dose Escalation (Accelerated Titration)ExperimentalVK-2019 QD in Accelerated Titration dose escalation cohorts enrolling EBV+ NPC
Receives: Drug: VK-2019
Phase 1 Dose Escalation (Rolling Six)ExperimentalVK-2019 QD in Rolling Six dose escalation cohorts enrolling EBV+ NPC.
Receives: Drug: VK-2019
Phase 1 Dose Expansion(s)ExperimentalVK-2019 QD in expansion cohorts that may be opened at doses that meet pre-specified criteria for clinical and/or biological activity.
Receives: Drug: VK-2019
Phase 2a Dose Expansion(s)ExperimentalVK-2019 QD in expansion cohorts that may be opened at doses that meet pre-specified efficacy criteria in Phase 1 Dose Escalation cohorts.
Receives: Drug: VK-2019

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All Cohorts: The Frequency, Severity, and Duration of AEs and DLTs, AEs Leading to Discontinuation, and AEs Leading to Death.

    Measured: 24 months

Secondary outcomes (1)

  1. Phase 1 Dose Escalation and Dose Expansion Cohorts: ORR

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2018
  2. Study start4 Apr 2019
  3. Primary completion23 Jun 2020
  4. Study completion8 Aug 2020

Why it stopped: Lack of efficacy

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03682055
Sponsor's protocol ID
VK-2019-001
Status last verified
Jul 2023
First submitted
20 Sep 2018
Last updated
15 Aug 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Young LS. Epstein-Barr virus at 50-future perspectives. Chin J Cancer. 2014 Nov;33(11):527-8. doi: 10.5732/cjc.014.10208.

    PubMed 25367333

  • Young LS, Dawson CW. Epstein-Barr virus and nasopharyngeal carcinoma. Chin J Cancer. 2014 Dec;33(12):581-90. doi: 10.5732/cjc.014.10197. Epub 2014 Nov 21.

    PubMed 25418193

  • Tsao SW, Tsang CM, Lo KW. Epstein-Barr virus infection and nasopharyngeal carcinoma. Philos Trans R Soc Lond B Biol Sci. 2017 Oct 19;372(1732):20160270. doi: 10.1098/rstb.2016.0270.

    PubMed 28893937

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VK-2019 in people with Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, run by Cullinan Therapeutics Inc. at 6 sites in 5 countries.

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 17 inclusion and 15 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: stopped early, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, China, France, Hong Kong, Singapore. 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?

Yes. Results are posted in the registry (first posted 15 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cohorts: The Frequency, Severity, and Duration of AEs and DLTs, AEs Leading to Discontinuation, and AEs Leading to Death. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03682055, which also lists 3 linked publications.

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 15 Aug 2023.

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