Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 metastat...
Eligibility Criteria
Inclusion
- Key
- 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
- 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 (CNS) metastases
- Cardiopulmonary dysfunction, including inadequate left ventricular ejection function at baseline, less than 50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
- QT interval corrected through use of Fridericia's formula (QTcF) \> 470 milliseconds (ms)
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03451162
Start Date
April 17 2018
End Date
July 16 2021
Last Update
August 5 2024
Active Locations (5)
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1
Yale Cancer Center
New Haven, Connecticut, United States, 06520
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 11101
4
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203