Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer


This first-in-human, Phase 1, open-label, multicenter, dose-escalation study will evaluate the safety, tolerability, and PK of DHES0815A as a single agent in participants with advanced and/or metastatic HER2-positive breast cancer for whom established treatment has proven ineffective or intolerable or is unavailable. The study may include a dose-expansion cohort (based on an ongoing assessment of the totality of data obtained in this study) to further assess safety, tolerability, PK, and preliminary anti-tumor activity.

Study Start Date

February, 27 2018

Estimated Completion Date

November 2021


  • Drug: DHES0815A

Study ID

Genentech, Inc. -- GO39869



Trial ID


Study Type


Trial Phase

Phase 1

Enrollment Quota



Genentech, Inc.


Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease by RECIST v1.1 with at least one measurable target lesion
  • Locally advanced or metastatic HER2-positive breast cancer that has relapsed or is refractory to established therapies
  • Adequate hematologic and end-organ function
  • For dose-expansion cohort only: no more than two prior systemic chemotherapy-containing regimens in the advanced/metastatic setting (excluding trastuzumab emtansine, which is considered a targeted cytotoxic agent) Key

Exclusion Criteria

  • Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of DHES0815A
  • History of exposure to the protocol specified doses of anthracyclines
  • Pregnancy, lactation, or breastfeeding
  • Major surgical procedure within 4 weeks prior to Day 1
  • Evidence of a significant uncontrolled concomitant disease of the nervous system, pulmonary, autoimmune, renal, hepatic, endocrine, or gastrointestinal disorders
  • or a serious non-healing wound or fracture
  • Known active bacterial, viral, fungal, mycobacterial, or other infection
  • Clinically significant history of liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Untreated or active central nervous system metastases
  • Cardiopulmonary dysfunction, including inadequate left ventricular ejection function at baseline, less than 50% by either echocardiogram or multiple-gated acquisition scan
  • QT interval corrected through use of Fridericia's formula (QTcF) > 470 milliseconds




18 Years and older

Accepts Healthy Volunteers


Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Columbia Univ Medical Center - New York, New York 181.2 miles None None None
Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles None None None provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.