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.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
EBNA1 inhibitor
Stanford University, School of Medicine, Stanford Cancer Institute
Stanford, California, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Institut Gustave Roussy
Villejuif, France
All Cohorts: The Frequency, Severity, and Duration of AEs and DLTs, AEs Leading to Discontinuation, and AEs Leading to Death.
Time frame: 24 months
Phase 1 Dose Escalation and Dose Expansion Cohorts: ORR
Time frame: 24 months
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Hong Kong University - Queen Mary Hospital
Hong Kong, Hong Kong
National Cancer Centre Singapore
Singapore, Singapore