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

Description

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

Interventions

  • Drug: DHES0815A

Study ID

Genentech, Inc. -- GO39869

Status

Recruiting

Trial ID

NCT03451162

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

55

Sponsor

Genentech, Inc.

Key

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Columbia Univ Medical Center - New York, New York 44.8 miles None None None
Sarah Cannon Research Institute - Nashville, Tennessee 810.5 miles None None None

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