Breast Cancer Clinical Trial
Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer
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 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.
Eligibility Criteria
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
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There are 5 Locations for this study
New Haven Connecticut, 06520, United States
Boston Massachusetts, 02215, United States
New York New York, 10065, United States
Nashville Tennessee, 37203, United States
Seoul , 05505, Korea, Republic of
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