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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:April 17, 2018
End Date:January 1, 2022
Contact:Reference Study ID Number: GO39869 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase I, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of DHES0815A in Patients With HER2-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.


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
We found this trial at
6
sites
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Seoul,
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