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VK-2019 QD in Accelerated Titration dose escalation cohorts enrolling EBV+ NPC

VK-2019 QD in Rolling Six dose escalation cohorts enrolling EBV+ NPC.

VK-2019 QD in expansion cohorts that may be opened at doses that meet pre-specified criteria for clinical and/or biological activity.

VK-2019 QD in expansion cohorts that may be opened at doses that meet pre-specified efficacy criteria in Phase 1 Dose Escalation cohorts.

VK-2019

A. Dimitrios Colevas, MD

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).

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

Phase 1/2a Open Label, Multicenter Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus Positive Nasopharyngeal Cancer, With Pharmacokinetic and Pharmacodynamic Correlative Studies

National Cancer Institute (NCI)

Cullinan Therapeutics Inc.

Cohort 1 (Phase 1 Accelerated Titration)

Cohort 2 (Phase 1 Accelerated Titration)

Cohort 3 (Phase 1 Accelerated Titration)

Cohort 4 (Phase 1 Accelerated Titration)

Cohort 5 (Phase 1 Accelerated Titration)

Cohort 6 (Phase 1 Rolling 6)

Cohort 6 (Phase 1 Accelerated Titration)

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Hong Kong

United States

France

Region of Enrollment

Phill Gallacher

All Cohorts: The Frequency, Severity, and Duration of AEs and DLTs, AEs Leading to Discontinuation, and AEs Leading to Death.

Phase 1 Dose Escalation and Dose Expansion Cohorts: ORR

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1/2a Study of VK-2019 in Patients With Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (NPC)	NCT03682055	Nasopharyngeal ... Nasopharyngeal ...	VK-2019	18 Years -	Cullinan Therapeutics Inc.
Phase 1/2a Study of VK-2019 in Patients With Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (NPC)	NCT03682055	Nasopharyngeal ... Nasopharyngeal ...	VK-2019	18 Years -	Cullinan Therapeutics Inc.

Spots Global Cancer Trial Database for nasopharynx carcinoma