A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer

  • STATUS
    Recruiting
  • End date
    Jun 15, 2025
  • participants needed
    93
  • sponsor
    Zymeworks Inc.
Updated on 15 October 2021

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.

Description

Part 1 of the study will first evaluate the safety and tolerability and establish the recommended doses (RDs) of zanidatamab in combination with evorpacept (ALX148). Part 2 of the study will evaluate the anti-tumor activity of the combination of zanidatamab plus evorpacept (ALX148) at the RD levels in indication-specific expansion cohorts.

Details
Condition HER2-expressing Cancers, HER2-expressing Cancers, HER2-expressing Cancers, HER2-expressing Cancers
Treatment ALX148, Evorpacept, Zanidatamab
Clinical Study IdentifierNCT05027139
SponsorZymeworks Inc.
Last Modified on15 October 2021

Eligibility

Yes No Not Sure

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 not HER2-positive per the ASCO/CAP guidelines)
Part 2: HER2-positive gastroesophageal adenocarcinoma as defined per the ASCO/CAP gastric cancer-specific guidelines; 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 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 tissue for central laboratory testing of HER2 protein expression and gene amplification by IHC and ISH assays, respectively
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ functions
Adequate cardiac left ventricular function, as defined by a left ventricular ejection fraction (LVEF) 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA) obtained within 4 weeks prior to first dose of study treatment

Exclusion Criteria

Previous allogeneic stem cell transplant
Prior treatment with any anti-CD47 or anti-signal regulatory protein alpha (SIRP) agent
Prior or concurrent invasive malignancy whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen
Received systemic anticancer therapy within 4 weeks of starting study treatment (6 weeks for mitomycin C or nitrosoureas). Received radiotherapy within 2 weeks of the first dose of zanidatamab/evorpacept (ALX148)
Untreated brain metastases, symptomatic brain metastases, or radiation treatment for brain metastases within 4 weeks of start of study treatment
Known leptomeningeal disease
Active hepatitis
Infection with human immunodeficiency virus (HIV)-1 or HIV-2. (Exception: Subjects with well controlled HIV [e.g., CD4 > 350/mm3 and undetectable viral load] are eligible.)
QTc Fridericia (QTcF) > 470 ms
History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure
Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease
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