Breast Cancer Clinical Trial

A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers

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.

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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.

View Eligibility Criteria

Eligibility Criteria

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 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)

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

174

Study ID:

NCT03821233

Recruitment Status:

Recruiting

Sponsor:

Zymeworks Inc.

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There are 16 Locations for this study

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City of Hope
Duarte California, 91010, United States More Info
Niki Dipesh Patel, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Heather Han, MD
Principal Investigator
University of Chicago Medicine
Chicago Illinois, 60637, United States More Info
Chih-Yi Liao, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Komal Jhaveri, MD
Principal Investigator
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Efrat Dotan, MD
Principal Investigator
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Erika Hamilton, MD
Principal Investigator
NEXT Oncology
San Antonio Texas, 78229, United States More Info
Anthony Tolcher, MD
Principal Investigator
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States More Info
Alexander Spira, MD
Principal Investigator
Flinders Medical Centre
Adelaide , 5042, Australia More Info
Christos Karapetis, MBBS
Principal Investigator
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
Philippe Bedard, MD
Principal Investigator
Jewish General Hospital
Montreal Quebec, H3T1E, Canada More Info
Wilson Miller, MD
Principal Investigator
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of More Info
Keun-Wook Lee, MD, PhD
Principal Investigator
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of More Info
Yeul Hong Kim, MD, PhD
Principal Investigator
Seoul National University Hospital
Seoul , 03080, Korea, Republic of More Info
Do-Youn Oh, MD, PhD
Principal Investigator
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of More Info
Sun Young Rha, MD, PhD
Principal Investigator
Asan Medical Center
Seoul , 05505, Korea, Republic of More Info
Yoon-Koo Kang, MD, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

174

Study ID:

NCT03821233

Recruitment Status:

Recruiting

Sponsor:


Zymeworks Inc.

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