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This study is a First-In-Human clinical trial to assess the safety and preliminary efficacy of VK-2019, an orally administered EBNA1 inhibitor, for the treatment of patients with advanced nasopharyngeal carcinoma.
This is a first-in-human phase 1‑2a dose escalation‑trial of the oral EBNA1 targeting agent VK‑2019 in patients with Epstein-Barr Virus (EBV)-positive recurrent or metastatic nasopharyngeal carcinoma (NPC). Primary objectives include safety profile and PK evaluation to define Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). Secondary objectives include evaluation of anti‑tumor effect, anti‑EBV activity, food pharmacokinetic (PK) effect and pharmacodynamics.
Once daily dosing using an accelerated titration plan with intrapatient dose escalation is anticipated until Adverse Event (AE) rules are met for stopping the accelerated escalation phase, followed by reversion to a conventional 3+3 escalation plan until MTD has been defined.
There will be extensive blood and urine pharmacokinetic studies performed on all patients.
Extensive safety monitoring will include evaluation of blood counts, blood chemistries, urinalyses, pregnancy testing, EKGs, drug compliance and clinical evaluations focused on adverse event detection and monitoring.
Efficacy evaluation will be per RECIST criteria and pharmacodynamic (PD) evaluation will include blood and tumor tissue evaluations. The tumor tissue biopsies for PD will be limited to a subset of patients at the MTD.
There will be an expansion phase at the MTD, with a food effect sub‑study on a subset of patients treated at MTD.
All treatments will be conducted at the Stanford Cancer Institute (SCI) in Stanford, California. There are limited funds available to support travel to the investigational site. We expect travel to Stanford will be feasible for many patients. An overnight stay in the SCI area may be necessary to collect some PK effect samples.
Stanford University, School of Medicine, Stanford Cancer Institute
Not yet recruiting
The Wistar Institute
Published on BioPortfolio: 2018-09-28T06:43:12-0400
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