A Phase I Study of BGB-3245 in Patients with Metastatic Solid Tumors that Continue to Grow Despite Treatment

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Full Title

A First-in-Human, Phase 1a/1b, Open-Label, Dose-Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of the RAF Dimer Inhibitor BGB-3245 in Patients with Advanced or Refractory Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug BGB-3245 that can be given safely in patients with metastatic cancers that continue to grow despite treatment and contain a mutation in a protein in a molecular pathway called MAPK. The MAPK pathway plays a role in the control of cell growth and cell survival. Changes in the MAPK pathway (such as mutations) can lead to cancer spreading.

Researchers think that BGB-3245 may be an effective treatment for people with advanced solid tumors that have a MAPK pathway mutation. BGB-3245 is taken orally (by mouth).

Eligibility

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

  • Patients must have a metastatic solid tumor that persists despite treatment and has a mutation in the MAPK pathway, such as in the BRAF or K-RAS/N-RAS proteins.
  • Patients should recover from the serious side effects of prior therapies before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alison Schram at 646-888-5388.

Protocol

20-279

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators