Status:
COMPLETED
A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers
Lead Sponsor:
Zymeworks BC Inc.
Conditions:
HER2-expressing Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 stud...
Detailed 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 subse...
Eligibility Criteria
Inclusion
- Pathologically-confirmed diagnosis of breast cancer, gastroesophageal adenocarcinoma (GEA), or other HER2-expressing cancer with evidence of locally advanced (unresectable) and/or metastatic disease.
- Dose-escalation (Cohort 1): HER2-high advanced solid tumors
- Expansion (Cohort 2): HER2-high breast cancer
- Expansion (Cohort 3): HER2-high GEA
- Expansion (Cohort 4): HER2-high other non-breast and non-GEA cancers
- 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
- Patients with HER2-high breast cancer must have received prior treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1)
- Patients with HER2-high GEA must have received prior treatment with trastuzumab
- Sites of disease assessible per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Dose-escalation: measurable or non-measurable disease
- Expansion: measurable disease
- 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
- History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure (CHF)
- Clinically significant infiltrative pulmonary disease not related to lung metastases
- Active hepatitis B or hepatitis C infection or other known chronic liver disease
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment)
- Known history of human immunodeficiency virus (HIV) infection
- Brain metastases: Untreated CNS metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as patients who are off steroids and anticonvulsants and are stable for at least 1 month at the time of screening).
- Known leptomeningeal disease (LMD)
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2024
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03821233
Start Date
April 15 2019
End Date
October 8 2024
Last Update
January 29 2025
Active Locations (16)
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1
City of Hope
Duarte, California, United States, 91010
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
University of Chicago Medicine
Chicago, Illinois, United States, 60637
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065