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
Primary Objective: To characterize the anti tumor effect of VK 2019 in subjects with EBV related cancer. Secondary Objective: 1. To characterize the safety profile, survival, PK and PD in the studied subject populations 2. To explore clinical activity and safety on subjects with post transplant lymphoproliferative disorder (PTLD) and EBV related lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
VK-2019 binds to EBNA1 and inhibits EBNA1 DNA binding activity. VK-2019 API is synthesized by Anthem BioSciences Pvt. Ltd and formulated into capsules by Emerson Resources Inc,
Stanford University
Stanford, California, United States
Response rate
Response rate to VK 2019 in EBV related NPC subjects will be assessed using RECIST v 1.1 criteria. Response Evaluable Subjects: All treated subjects with measurable disease at baseline and one of the following: 1) at least one post dose tumor assessment, 2) discontinuation prior to the first efficacy assessment due to clinical disease progression or toxicity or 3) death either on treatment or within 28 days of last VK 2019 dose.
Time frame: 12 months
Progression free survival
Progression free survival (PFS) per RECIST v 1.1 from time of subject registration. Reported as the number of subjects remaining alive at the assessment timepoint, without progression.
Time frame: 24 months
Overall survival
Overall survival from time of subject registration. Reported as the number of subjects remaining alive at the assessment timepoint.
Time frame: 24 months
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration (AUC) for VK 2019 and metabolites will be estimated using non compartmental analysis. Analysis population is defined as all enrolled subjects treated who have at least one of the PK parameters of interest. The median AUC values by cohort, with standard deviation, obtained after 2 cycles will be reported.
Time frame: Day 56 (ie, Day 0 Cycle 3 after 2, (each cycle is 28 days)
Time to maximum plasma concentration (Tmax),
Time to maximum plasma concentration (Tmax) for VK 2019 and metabolites will be collected, Analysis population is defined as all enrolled subjects treated who have at least one of the PK parameters of interest. The median value of Tmax by cohort, with standard deviation, obtained after 2 cycles will be reported.
Time frame: Day 56 (ie, Day 0 Cycle 3 after 2, (each cycle is 28 days)
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Peak Plasma Concentration (Cmax)
Maximum plasma concentration (Cmax) will be collected. Analysis population is defined as all enrolled subjects treated who have at least one of the PK parameters of interest. The median value of Cmax by cohort, with standard deviation, obtained after 2 cycles will be reported.
Time frame: Day 56 (ie, Day 0 Cycle 3 after 2, (each cycle is 28 days)
Safety profile
Measure the number of adverse events (AEs), Serious adverse events (SAEs), and Dose Limiting Toxicities (DLTs) by cohort, for up to 12 months.
Time frame: 12 months
Pharmacodynamic EBV DNA
Median difference from treatment to Day 56 (ie, Day 0 Cycle 3 after 2 28-day cycles) for the levels of cell free plasma EBV DNA by cohort, with standard deviation will be measured
Time frame: Day 56 (ie, Day 0 Cycle 3 after,2 (each cycle is 28-day)