A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers
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ClinicalTrials.gov Identifier: NCT03821233 |
Recruitment Status :
Recruiting
First Posted : January 29, 2019
Last Update Posted : April 27, 2022
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Sponsor:
Zymeworks Inc.
Information provided by (Responsible Party):
Zymeworks Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | January 28, 2019 | ||||
First Posted Date ICMJE | January 29, 2019 | ||||
Last Update Posted Date | April 27, 2022 | ||||
Actual Study Start Date ICMJE | April 15, 2019 | ||||
Estimated Primary Completion Date | August 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers | ||||
Official Title ICMJE | A Phase 1 Study of ZW49 in Patients With Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers | ||||
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 study, and to assess the safety and tolerability of ZW49. Eligible patients include those with locally advanced (unresectable) or metastatic HER2-expressing cancers. | ||||
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 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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HER2-expressing Cancers | ||||
Intervention ICMJE | Drug: ZW49
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Study Arms ICMJE | Experimental: ZW49
Intervention: Drug: ZW49
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
174 | ||||
Original Estimated Enrollment ICMJE |
69 | ||||
Estimated Study Completion Date ICMJE | August 2025 | ||||
Estimated Primary Completion Date | August 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, Australia, Korea, Republic of, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03821233 | ||||
Other Study ID Numbers ICMJE | ZWI-ZW49-101 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Zymeworks Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Zymeworks Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Zymeworks Inc. | ||||
Verification Date | April 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |