A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)

NCT06789159 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: iRISID-2024-0941R01CA282411JT 35884
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase Ib in adult patients with relapsed or refractory EBV-positive DLBCL using daily oral dosing of VK-2019 in three dose escalation cohorts: 600 mg/day, 1200 mg/day, 1800 mg/day for 28 days (cycle), until progression or toxicity.

Conditions

Diffuse Large B Cell Lymphoma Refractory; Diffuse Large B Cell Lymphoma Relapsed; Epstein-Barr Virus (EBV) Infection

Outcome Measures

Primary Outcomes (1)

• Safety Dose- Maximum Tolerated Dose

  • The maximum tolerated dose (MTD) of single agent VK-2019 based upon treatment emergent AE (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], Version 5.0).

  At the end of Cycle 1 (each cycle is 28 days), until disease progression or unacceptable toxicity. All Patients will be followed for a total of 3 years.

Study Arms (3)

Treatment (VK-2019 Dose 600mg)

EXPERIMENTAL

Dose cohort A will dose at 600mg. VK-2019 will be administered daily starting on day 1 of cycle 1 (D1C1). Dose cohort A will dose at 600 mg dose. Treatment cycles will repeat every 28 days , in the absence of disease progression or unacceptable toxicity.

Drug: VK-2019

Treatment (VK-2019 Dose 1200mg)

EXPERIMENTAL

Dose cohort B will dose at 1200mg.VK-2019 will be administered daily starting on day 1 of cycle 1 (D1C1). Dose cohort B will dose at 1200 mg dose. Treatment cycles will repeat every 28 days , in the absence of disease progression or unacceptable toxicity.

Drug: VK-2019

Treatment (VK-2019 Dose 1800mg)

EXPERIMENTAL

Dose cohort C will dose at 1800mg. VK-2019 will be administered daily starting on day 1 of cycle 1 (D1C1). Dose cohort C will dose at 1800 mg dose. Treatment cycles will repeat every 28 days , in the absence of disease progression or unacceptable toxicity.

Drug: VK-2019

Interventions

VK-2019 DRUG

VK-2019 will be administered daily starting on day 1 of cycle 1 (D1C1). Dose cohort A will dose at 600 mg dose cohort B 1200 mg and dose cohort C 1800 mg. Treatment cycles will repeat every 28 days , in the absence of disease progression or unacceptable toxicity.

Treatment (VK-2019 Dose 1200mg); Treatment (VK-2019 Dose 1800mg); Treatment (VK-2019 Dose 600mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained prior to any protocol mandated assessment.
• Age ≥ 18 years.
• Patient must have relapsed or refractory EBV-positive DLBCL after a minimum of 2 prior regimens of systemic therapy.
• Patient must have exhausted all available standard of care treatment options that could potentially provide clinical benefit.
• Toxicities related to prior therapy must have returned to Grade 1 or less, or if chronic must be stable. Peripheral neuropathy must be Grade 2 or less
• Prior anti-cancer treatment must have been completed greater than 2 weeks prior to study day 1.
• Patients must have measurable disease, as defined by IWG 2007 criteria.
• ECOG performance status score of ≤2
• Adequate organ function as defined by the following criteria:
• Absolute neutrophil count \> 1,500/microl (stable off any growth factor within 1 week of study drug administration)
• Hemoglobin \> 9 g/dL (transfusion to achieve this level is permitted)
• Platelet count \> 75,000/microl (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;
• Creatinine clearance≥ 60 ml/min as calculated per Cockcroft and Gault equation.

You may not qualify if:

• Patients with 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; patents with effectively treated conditions (e.g. stenting for CAD) are eligible.
• Patients with metastatic disease with active central nervous system (CNS) involvement, defined as parenchymal brain or leptomeningeal involvement.
• Concurrent administration of herbal preparations.
• A serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy.
• Patients currently taking drugs that inhibit or induce OATP1B1 or OATP1B3 within 5 half- lives of that agent. Examples are included in Appendix B.
• Patients currently taking drugs that are proton pump inhibitors (PPIs) within 5 half- lives of that agent. Examples are included in Appendix B.
• Patients who have received a prior organ allograft or allogeneic bone marrow transplant are eligible but must have no evidence of active GVHD and be off immunosuppressive drugs.
• 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.
• Patients with corrected QT by Fridericia's formula (QTcF) of \>470 ms are excluded.
• Patients with Post-Transplant Lymphoproliferative Disease (PTLD) are excluded.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator
• The Wistar Institute: collaborator

Study Sites (1)

Honickman Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections

Study Officials

• Michael S Wysota, MD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael S Wysota, MD

CONTACT

215-955-8988; Michael.Wysota@jefferson.edu

Ariel Kobylak

CONTACT

267-319-3598; Ariel.Kobylak@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 23, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)