Zanidatamab for HER2-expressing Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Northwest Medical Specialties, Tacoma, WA
HER2-expressing Cancers
Zanidatamab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called zanidatamab can be used to treat patients with advanced (locally advanced [inoperable] and/or metastatic) human epidermal growth factor receptor 2 (HER2)-expressing cancer.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Zanidatamab will improve 4 primary outcomes and 13 secondary outcomes in patients with HER2-expressing Cancers. Measurement will happen over the course of Up to 4 weeks.

Up to 2 years
Clinical benefit rate (CBR)(Part 2)
Confirmed objective response rate (ORR)(Part 2)
Disease control rate (DCR)(Part 2)
Duration of response (DOR)(Part 2)
Overall survival (OS)(Part 2)
Progression-free survival (PFS)(Part 2)
Up to 4 weeks
Incidence of dose-limiting toxicities (DLTs; Part 1)
Up to 6 months
Progression-free survival 6 (PFS6)(Part 2)
Up to 7 months
Incidence of AEs (Part 1)
Incidence of AEs (Part 2)
Incidence of anti-drug antibodies (ADAs)(Part 2)
Incidence of clinical laboratory abnormalities (Part 1)
Incidence of clinical laboratory abnormalities (Part 2)
Maximum serum concentration of zanidatamab and ALX148 (Part 2)
Maximum serum concentration of zanidatamab and evorpacept (ALX148) (Part 2)
Trough concentration of zanidatamab and ALX148 (Part 2)
Trough concentration of zanidatamab and evorpacept (ALX148) (Part 2)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Zanidatamab plus evorpacept (ALX148)
1 of 1
Experimental Treatment

This trial requires 93 total participants across 1 different treatment group

This trial involves a single treatment. Zanidatamab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Zanidatamab plus evorpacept (ALX148)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Northwest Medical Specialties - Tacoma, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What causes her2-expressing cancers?

"Germline mutations in HER2 are a candidate for causation of about 25-30% of germline mutations in patients with breast cancer. About 1% to 3% patients with breast cancer may be diagnosed with her2-expressing tumors as a somatic event unrelated to germline HER2-expression. In these HER2-expression cases, the mechanism involved involves somatic disruption of the HER2 locus on chromosome 17. HER2-neu gene amplification in these cases may either be a consequence of the chromosome 17 inactivation or be a pathogenetically relevant event causing the HER2-neu expression." - Anonymous Online Contributor

Unverified Answer

What are the signs of her2-expressing cancers?

"Her2 sign can be defined as at least four of the following 5 criteria and one of the 4 conditions. Her2 test is an appropriate screening test for the patient with these signs. In the 5-point scale, if any one of points are ≥2, the test should be considered for the patient. Clinically, these signs may suggest the possibility for inclusion into a clinical trial." - Anonymous Online Contributor

Unverified Answer

What is her2-expressing cancers?

"Her2-expressing cancers are a diverse group of malignancies characterized by the presence of the Her2 gene. This article describes a general overview of these classes of tumours and gives their incidence and clinical relevance." - Anonymous Online Contributor

Unverified Answer

Can her2-expressing cancers be cured?

"The prevalence rate of patients with Her2-positive cancers has decreased during our 10-year study, despite universal use of a standardized diagnostic test. Recent findings suggest that testing the Her2 expression level of early lesions is a good therapeutic decision-making tool for patients with breast cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for her2-expressing cancers?

"Treatment differs significantly for the subset of women with HER2-positive breast cancer, but it remains a controversial subject among clinical oncologists. Because of the absence of conclusive evidence, most clinicians opt to follow the ACCOG recommendations. If there is any benefit to a specific treatment regimen, the patients are offered it. However, the data, if any, are limited, and the benefits rarely outweigh the risk of the chemotherapy." - Anonymous Online Contributor

Unverified Answer

How many people get her2-expressing cancers a year in the United States?

"About 100,000 cases of HER2-positive breast cancer are diagnosed each year in the United States. Of these, at least 75% will remain undetected and untreated." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in zanidatamab for therapeutic use?

"Since zanidatamabs have been proposed as a new therapeutical strategy and their effectiveness in targeting HER2-positive carcinomas has been already demonstrated, further evaluation appears to be warranted." - Anonymous Online Contributor

Unverified Answer

Does zanidatamab improve quality of life for those with her2-expressing cancers?

"Results from a recent clinical trial supports the current recommendation that zanidatamab is a reasonable option in the treatment of HR-positive, metastatic breast cancer; the only negative finding was an increase in grade 1 and 2 stomatitis (dysphagia and ulceration at the site of infusion). However, overall, grade 2 stomatitis is manageable and does not diminish the quality of life of patients treated." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of her2-expressing cancers?

"As we have shown, most of patients with HER2+ tumors developed these lesions during the course of their disease and did not develop them at curative surgeries. We think that the most frequent cause of HER2+ cancer in our sample is not related to HER2 overexpression. After further studies, the HER2 status of the primary tumor seems to be related to disease presentation and prognosis after surgery. These data are significant because if one can ascertain why the primary tumor is HER2+ and why the tumor developed during the course of the disease, the treatment will be optimized. Recent findings point to the necessity of using a new approach in determining the prognosis and the treatment of patients with HER2+ breast cancer." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating her2-expressing cancers?

"It is important for patients that treatment for her2-expressing cancers are tailored to each patient rather than chosen on a basis of ethnicity and cancer type as previously assumed, because there are large differences in disease biology between patient populations. Therefore, new treatments and therapeutic approaches are necessary to achieve efficient, high-quality patient care and the avoidance of unnecessary treatment delays." - Anonymous Online Contributor

Unverified Answer

Is zanidatamab typically used in combination with any other treatments?

"The incidence of toxicity, especially in subjects>55 years old, warrants a more cautious approach toward the use of this drug. A clear understanding of the most efficient combination of patients and therapies will allow better treatment and optimize prognosis of this illness." - Anonymous Online Contributor

Unverified Answer

What is the latest research for her2-expressing cancers?

"HER2 expression in cancers has not been proven to be associated with worse prognosis. However, the expression of this receptor may be related to shorter treatment times (patients treated without trastuzumab had treatment-free survival times twice as long as patients treated with this drug (p = 0.001)). Further work is needed to verify the effectiveness of the trastuzumab-based treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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