A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers (NCT03821233) | Clinical Trial Compass
CompletedPhase 1
A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers
United States, Australia, Canada112 participantsStarted 2019-04-15
Plain-language 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 study, and to assess the safety and tolerability of ZW49. Eligible patients include those with locally advanced (unresectable) or metastatic HER2-expressing cancers.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* 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 Criteria:
* History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically sig…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose-limiting toxicities (DLTs)
Timeframe: Up to 4 weeks
2
Incidence of adverse events
Timeframe: Up to 7 months
3
Incidence of lab abnormalities
Timeframe: Up to 7 months
4
Incidence of electrocardiogram (ECG) and left ventricular ejection fraction (LVEF) abnormalities