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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HER2-expressing Cancers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

single-arm, open-label, multi-cohort, multi-center study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zanidatamab plus evorpacept (ALX148)

Group Type EXPERIMENTAL

Zanidatamab

Intervention Type DRUG

Administered intravenously (IV)

Evorpacept

Intervention Type DRUG

Administered IV

Interventions

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Zanidatamab

Administered intravenously (IV)

Intervention Type DRUG

Evorpacept

Administered IV

Intervention Type DRUG

Other Intervention Names

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ZW25 JZP598 ZIIHERA® ALX148

Eligibility Criteria

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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 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 (SIRPα) 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 (stereotactic radiosurgery and whole brain radiation) for brain metastases within 2 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No