HER2-expressing Cancers Clinical Trial
Phase I Trial of ZW25 in Patients With Locally Advanced (Unresectable) and/or Metastatic HER2-expressing Cancers
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.
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. ;
|Contact||Linda Lai, PhD|
|Start date||September 2016|
|Completion date||December 2018|