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.
This is an open label, dose-escalation phase Ib study with biomarker assessments to determine the safety and tolerability of single agent VK-2019 in patients with relapsed or refractory EBV-positive lymphomas. Each treatment cycle is comprised of a daily dose of VK-2019 administered orally for 28 days with a response assessment every 3 cycles. All subjects will be monitored for survival for 3 years. 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. Should dose cohort 1 result in unacceptable toxicity, the protocol will be amended to include a dose (-1) cohort of VK-2019 given in the same fashion as above. Patients who achieve at least stable disease (SD, PR, or CR) after completing 3 cycles can continue receiving therapy. Patients who have progressive disease (PD) after cycle 3 will discontinue protocol treatment. All patients will be followed for a total of 3 years. Protocol therapy will be discontinued at any time if a patient withdraws consent, has progressive disease, unacceptable toxicity, or pregnancy is suspected.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Honickman Center
Philadelphia, Pennsylvania, United States
RECRUITINGSafety 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).
Time frame: 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.
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