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Clinical Trial Summary

To evaluate the maximal tolerated dose (MTD), optimal biological dose (OBD) or other recommended dose (RD), and overall safety and tolerability of ZW25 in patients with locally advanced (unresectable) and/or metastatic HER2-expressing cancers.


Clinical Trial Description

Part 1, Dose Escalation: Patients with any HER2-expressing cancer that is either HER2 1+, 2+ or 3+ by immunohistochemistry (IHC) and has progressed after all standard of care therapies will receive escalating doses of ZW25 in order to identify either the highest dose of study drug possible that will not cause unacceptable side effects or the dose of study drug which is thought to be associated with optimal biologic activity.

Part 2, Dose Expansion: Patients will be enrolled into one of the below cohorts based the level of HER2 expression and cancer type.

- Cohort 1: HER2 IHC 2+/FISH negative breast cancer

- Cohort 2: HER2 IHC 3+ or HER2 IHC 2+/FISH positive breast cancer

- Cohort 3: HER2 IHC 2+/FISH negative gastric/ GEJ cancer

- Cohort 4: HER2 IHC 3+ or HER2 IHC 2+/FISH positive gastric/GEJ cancer

- Cohort 5: Any other HER2 IHC 3+ or FISH positive cancer

Patients in Part 2 will receive the dose of study drug identified in Part 1 of the study. These patients will be followed to further evaluate the safety of ZW25 as well as to explore anti-tumor activity.

Part 3, Combination Therapy Expansion: Patients with HER2-expressing breast or gastric/GEJ cancers will be treated with ZW25 in combination with one of several chemotherapy regimens including paclitaxel, capecitabine and vinorelbine. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02892123
Study type Interventional
Source Zymeworks Inc.
Contact Linda Lai, PhD
Phone (206) 260-2078
Email linda.lai@zymeworks.com
Status Recruiting
Phase Phase 1
Start date September 2016
Completion date December 2018