A Phase I Study of ERAS-601 Alone or with a MEK inhibitor for People with Advanced or Metastatic Solid Tumors

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Full Title

FLAGSHP-1: An Open-Label, Multi-Center Phase 1/1b Dose Escalation and Expansion Study of ERAS-601 SHP2 Inhibitor as a Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with Advanced or Metastatic Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug ERAS-601 that can be given alone and in combination with a MEK inhibitor drug in patients with advanced solid tumors. Patients in this study will either take ERAS-601 alone or ERAS-601 with a MEK inhibitor. Both medications are taken orally (by mouth).

Who Can Join

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

  • Patients must have an advanced or metastatic solid tumor that cannot be treated with standard therapies or for which no standard therapies exist. 
  • Patients should recover from the serious side effects of prior treatments before entering the study.
  • 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. Ezra Rosen at 646-888-6955.

Protocol

21-157

Phase

I

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT04670679