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Daiichi Sankyo U31402-A-J101: Phase 1/2, multi-center, open-label, multiple-dose first-in-human study of U3-1402, in subjects with HER3-positive metastatic breast cancer

Description

This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study, for the dose escalation part, is:

  • To assess safety and tolerability of U3-1402
  • To determine the maximum tolerated dose of U3-1402

The primary objective of this study, for the dose finding part, is:

  • To assess safety and evaluate efficacy of U3-1402
  • To assess the safety of alternative dosing schedule(s) of U3-1402
  • To determine the recommended dose(s) for expansion (RDEs) of U3-1402

The primary objective of this study, for the dose expansion part, is:

  • To assess safety and evaluate efficacy of U3-1402 at the RDEs in subjects with human epidermal growth factor receptor 2 (HER2)-negative and hormone receptor (HR)-positive breast cancer

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are at least 18 years old and live in the United States and those who are at least 20 years old and live in Japan
  • Have a pathologically documented advanced, unresectable or metastatic breast cancer
  • Have documented HER3-positive disease measured by immunohistochemistry
  • Have a disease that is refractory to or intolerable with standard treatment, or who no longer have standard treatment available
  • Have an Eastern Cooperative Oncology Group Performance Status of 0-1
  • Have a left ventricular ejection fraction of greater than or equal to 50 percent
  • Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Have received two to six prior chemotherapy regimens for breast cancer, at least two of which were administered for treatment of advanced, unresectable or metastatic disease (At least one prior chemotherapeutic regimen must have included a taxane, administered in the neoadjuvant, adjuvant or advanced setting.) (for dose finding and expansion parts)
  • Are able to submit a fresh tumor biopsy sample prior to starting study treatment if not already submitted for HER3 expression (for dose expansion part)
  • Have documented HER2-negative expression according to the American Society of Clinical Oncology and College of American Pathologists guidelines (for dose expansion part)
  • Have documented hormone (estrogen and/or progesterone) receptor (HR)-positive disease (for dose expansion part)

Excluding patients who:

  • Have had prior treatment with a HER3 antibody
  • Have had prior treatment with an antibody-drug conjugate, which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., DS-8201)
  • Have a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or serious cardiac arrhythmia that has required treatment
  • Have a medical history of myocardial infraction or unstable angina
  • Have a corrected QT prolongation of more than 450 milliseconds in males and more than 470 milliseconds in females
  • Have a medical history of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis and severe radiation pneumonitis) or are suspected of having these diseases by imaging at screening period
  • Have clinically significant corneal disease

Learn more about breast cancer

     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Damien Hansra