A Phase I Study of U3-1402 to Treat EGFR-Mutant Non-Small Cell Lung Cancer

Full Title

U31402-A-U102: A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects with Metastatic or Unresectable EGFR-Mutant Non-Small Cell Lung Cancer

Purpose

Most non-small cell lung cancers (NSCLC) with alterations in a protein called the epidermal growth factor receptor (EGFR) that are treated with EGFR-targeting drugs (such as erlotinib, afatinib, or gefitinib) eventually come back or continue to grow. In many patients, the resistance to EGFR inhibitors is due to a mutation called EGFR T790M, and those patients may receive another drug called osimertinib.

Patients whose cancer progresses after erlotinib, afatinib, or gefitinib and who do not have an EGFR T790M mutation, however, have no further targeted therapy options. In addition, for patients whose disease progresses during osimertinib treatment, there are no other choices for targeted therapy. In this study, researchers are evaluating the safety and preliminary effectiveness of the investigational drug U3-1402 for these patients.

U3-1402 is an antibody attached to a chemotherapy drug. U3-1402 targets a protein in NSCLC called HER3, which is thought to be present in higher amounts after treatment with EGFR inhibitors. U3-1402 is designed to bring chemotherapy inside HER3-positive cancer cells and kill them. It is given intravenously (by vein).

Eligibility

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

  • Patients must have inoperable or metastatic EGFR-mutant NSCLC that has grown despite treatment with erlotinib, afatinib, or gefitinib.
  • 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. Helena Yu at 646-888-4274.

Protocol

17-559

Phase

I

Investigator

Co-Investigators