Phase 1/2a Study of VK-2019 in Patients With Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (NPC)

  • STATUS
    Not Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    60
  • sponsor
    Cullinan Apollo Corporation
Updated on 25 January 2021
Investigator
Myles Clancy
Primary Contact
Hong Kong University - Queen Mary Hospital (4.4 mi away) Contact
+5 other location
platelet count
cancer
absolute neutrophil count
measurable disease
carcinoma
growth factor
serum bilirubin
neutrophil count
neuropathy
nasopharyngeal carcinoma
vk-2019

Summary

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.

Description

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).

Details
Condition Carcinoma, Nasopharyngeal Cancer, Vulvar Dysplasia and Carcinoma, Advanced Malignancies
Treatment VK-2019
Clinical Study IdentifierNCT03682055
SponsorCullinan Apollo Corporation
Last Modified on25 January 2021

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