A Phase I Study of Pyrotinib for HER2-Positive or Mutant Cancers

Full Title

SHRUS 1001: A Two-Part, Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pyrotinib in Patients with HER2-Positive Solid Tumors whose Disease Progressed on Prior HER2 Targeted Therapy

Purpose

HER2 is a protein that drives the growth of some cancers. Drugs such as trastuzumab and lapatinib work against cancers by inhibiting HER2, but in some cases the cancer continues to grow despite these treatments.

Pyrotinib is an investigational medication that blocks the HER2 protein, stopping it from causing cancer cell growth. The purpose of this study is to assess the safety of pyrotinib in patients with HER2-positive non-small cell lung cancer or breast cancer that has continued to grow despite prior treatment. Pyrotinib 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 HER2-mutant non-small cell lung cancer or HER2-positive metastatic breast cancer that continued to grow despite prior treatment.
  • 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 for patients age 18 and older.

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

Protocol

17-638

Phase

I

Disease Status

Newly Diagnosed

Investigator

Co-Investigators