Asan Medical Center | Clinical Trial Center
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This is a first-in-human, Phase 1, multicenter, open-label, dose-escalation study to establish the maximum-tolerated dose (MTD) or recommended dosage (RD) of ZW49, the investigational agent under study, and to assess the safety and tolerability of ZW49. Eligible patients include those with locally advanced (unresectable) or metastatic HER2-expressing cancers.
Full description
The study will use a 3+3 dose-escalation study design to evaluate the safety and tolerability of ZW49 and to determine the MTD or RD of ZW49 for further study. Selected expansion cohorts will be subsequently opened based upon Safety Monitoring Committee (SMC) recommendation and sponsor approval to further evaluate the safety and tolerability of ZW49 at the MTD or RD and to assess preliminary anti-tumor activity.
Enrollment
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Inclusion criteria
Pathologically-confirmed diagnosis of breast cancer, gastroesophageal adenocarcinoma (GEA), or other HER2-expressing cancer with evidence of locally advanced (unresectable) and/or metastatic disease.
Progressive disease that has progressed on or been refractory to all standard of care. Patients who were intolerant to or ineligible for standard therapy may be eligible if the reasons are carefully documented and approval is provided by the sponsor medical monitor
Sites of disease assessible per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
ECOG performance status score of 0 or 1
Adequate organ function
Adequate cardiac left ventricular function, as defined by a LVEF >/= institutional standard of normal
Exclusion criteria
Primary purpose
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Interventional model
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112 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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