Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers
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ClinicalTrials.gov Identifier: NCT02892123 |
Recruitment Status :
Active, not recruiting
First Posted : September 8, 2016
Last Update Posted : April 18, 2024
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Tracking Information | |||
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First Submitted Date ICMJE | August 23, 2016 | ||
First Posted Date ICMJE | September 8, 2016 | ||
Last Update Posted Date | April 18, 2024 | ||
Actual Study Start Date ICMJE | September 30, 2016 | ||
Estimated Primary Completion Date | June 1, 2024 (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 |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers | ||
Official Title ICMJE | Phase I Trial of ZW25 in Patients With Locally Advanced (Unresectable) and/or Metastatic HER2-expressing Cancers | ||
Brief Summary | This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-expressing cancers. This study will also the evaluate the way the body absorbs, distributes, and eliminates ZW25 (pharmacokinetics or PK). | ||
Detailed Description | Part 1 of the study will evaluate increasing doses of ZW25 to find the highest dose of ZW25 that does not cause unacceptable side effects (maximum-tolerated dose or MTD), the lowest safe dose with the highest rate of effectiveness (optimal biological dose or OBD), and/or other recommended dosages (RDs) of ZW25 in up to 7 dose-specific cohorts. Eligible patients include those with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after receipt of all therapies known to confer clinical benefit (or ineligible to receive therapy). Part 2 of the study will further evaluate the safety, tolerability, and efficacy of ZW25 in patients with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after receipt of all therapies known to confer clinical benefit (or ineligible to receive therapy) in up to 5 separate disease-specific cohorts. Part 3 of the study will evaluate the safety, tolerability, and efficacy of ZW25 combined with selected chemotherapy agents, including paclitaxel, capecitabine, vinorelbine, or capecitabine and tucatinib. Patients with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after at least 1 and no more than 3 prior systemic chemotherapy regimens will be evaluated in this part of the study. |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HER2-expressing Cancers | ||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: ZW25 (Zanidatamab) Monotherapy and ZW25 Combination Therapy
Interventions:
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Publications * | Meric-Bernstam F, Beeram M, Hamilton E, Oh DY, Hanna DL, Kang YK, Elimova E, Chaves J, Goodwin R, Lee J, Nabell L, Rha SY, Mayordomo J, El-Khoueiry A, Pant S, Raghav K, Kim JW, Patnaik A, Gray T, Davies R, Ozog MA, Woolery J, Lee KW. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: a phase 1, dose-escalation and expansion study. Lancet Oncol. 2022 Dec;23(12):1558-1570. doi: 10.1016/S1470-2045(22)00621-0. Epub 2022 Nov 16. | ||
* 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 | Active, not recruiting | ||
Actual Enrollment ICMJE |
279 | ||
Original Estimated Enrollment ICMJE |
30 | ||
Estimated Study Completion Date ICMJE | July 1, 2024 | ||
Estimated Primary Completion Date | June 1, 2024 (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 | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada, Korea, Republic of, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02892123 | ||
Other Study ID Numbers ICMJE | ZWI-ZW25-101 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Jazz Pharmaceuticals | ||
Original Responsible Party | Zymeworks BC Inc. | ||
Current Study Sponsor ICMJE | Jazz Pharmaceuticals | ||
Original Study Sponsor ICMJE | Zymeworks BC Inc. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Jazz Pharmaceuticals | ||
Verification Date | April 2024 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |