A Phase I Study of BVD-523 in Patients with Advanced Cancers

Full Title

A Phase 1 Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients with Advanced Malignancies


The purpose of Part 1 of this study is to find the highest dose of an investigational drug called BVD-523 that can be given safely to patients with advanced cancers that have continued to grow despite standard therapy, or for which no standard therapy exists. In Part 2 of the study, researchers will also observe the preliminary effectiveness of BVD-523 against a variety of cancers with specific gene mutations, including melanoma and lung, colorectal, and other cancers. This clinical trial is currently in Part 2.

BVD-523 works by blocking the functions of a protein called extracellular signal-related kinase (ERK), which is part of a major pathway involved in the growth and spread of several types of cancer. BVD-523 is a pill that is taken orally (by mouth).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an advanced cancer that is considered incurable.
  • Patients may have received prior therapy.
  • Patients must have cancers with certain genetic mutations in BRAF, NRAS, MEK, or ERK.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Bob Li at 646-888-4226.