A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing … (NCT05027139) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer
United States52 participantsStarted 2021-09-15
Plain-language summary
This study is being done to find out if zanidatamab when given with evorpacept (ALX148) is safe and can treat patients with advanced (locally advanced \[inoperable\] and/or metastatic) human epidermal growth factor receptor 2 (HER2)-expressing cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Locally advanced (inoperable) and/or metastatic HER2-expressing cancer based on local or central laboratory test results as follows:
* Parts 1 and 2: HER2-positive breast cancer as defined per American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines
* Parts 1 and 2: HER2-low breast cancer (defined as immunohistochemistry \[IHC\] 1+ or IHC 2+; AND is currently not and has never been HER2-positive per the ASCO/CAP guidelines)
* Part 2: HER2-positive gastroesophageal adenocarcinoma as defined per the ASCO/CAP gastric cancer-specific guidelines; or other HER2-overexpressing non-breast cancers (defined as IHC 3+; or IHC 2+ and in situ hybridization \[ISH\]+) per the ASCO/CAP guidelines for breast cancer
* Progression after or during the most recent systemic regimen of treatment for advanced cancer. For both Part 1 and Part 2, prior therapies must have included approved agents known to confer clinical benefit.
* Subjects with HER2-positive breast cancer who did not receive trastuzumab or pertuzumab due to medical contraindications will not be eligible for this study
* Subjects with HER2-low breast cancer who have received prior HER2-targeted therapy (other than trastuzumab deruxtecan, which is allowed but not required) will not be eligible for this study
* Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Willingness to undergo a new biopsy to provide a tumor tissu…
What they're measuring
1
Incidence of dose-limiting toxicities (DLTs; Part 1)
Timeframe: Up to 4 weeks
2
Incidence of AEs (Part 1)
Timeframe: Up to 7 months
3
Incidence of clinical laboratory abnormalities (Part 1)