ZW25 (Zanidatamab) for HER2-expressing Cancers

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Colorado Cancer Center, Aurora, CO
ZW25 (Zanidatamab) - Drug
Eligibility
18+
All Sexes
Eligible conditions
HER2-expressing Cancers

Study Summary

This study is evaluating whether a drug may help treat cancer.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether ZW25 (Zanidatamab) will improve 2 primary outcomes and 5 secondary outcomes in patients with HER2-expressing Cancers. Measurement will happen over the course of Up to 8 months.

Year 2
Progression free survival as defined by RECIST 1.1 criteria
Serum concentrations of ZW25
The proportion of patients who develop detectable anti-drug antibodies
The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria
The proportion patients who experience laboratory abnormalities and/or adverse events as defined by CTCAE v4.03 that are related to treatment (Part 1)
The proportion patients who experience laboratory abnormalities and/or adverse events as defined by CTCAE v4.03 that are related to treatment (Parts 2 and 3)
Up to 8 months
The proportion of patients who experience dose-limiting toxicities (DLTs) (Part 1)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
ZW25 (Zanidatamab) Monotherapy and ZW25 Combination Therapy

This trial requires 279 total participants across 2 different treatment groups

This trial involves 2 different treatments. ZW25 (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 and are in the first stage of evaluation with people.

ZW25 (Zanidatamab) Monotherapy and ZW25 Combination Therapy
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Vinorelbine
FDA approved
Capecitabine
FDA approved
Tucatinib
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

University of Colorado Cancer Center - Aurora, CO

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:
Breast cancer that is positive for the HER2 protein (3+ by IHC), or is positive for HER2 using the FISH assay and has progressed after prior treatment with trastuzumab, pertuzumab, and T-DM1 must be considered for treatment with neratinib. show original
Patients with colorectal cancer must have a KRAS gene that is not mutated in order to be treated with this particular cancer drug. show original
to be eligible for treatment with crizotinib In order to be eligible for crizotinib treatment, patients with NSCLC must have ALK not mutated, EGFR not mutated, and ROS1 not fused show original
Cohort 7 includes women with HER2-positive breast cancer who have had a progression of their cancer after prior treatment with trastuzumab, pertuzumab, and T-DM1. show original
HER2 is overexpressed on the surface of breast cancer or GEA cells, as determined by IHC and FISH. show original
, including chemotherapy, targeted therapies, and immunotherapy Patients in cohorts 1 through 3 have a type of cancer that has progressed after they have received all therapies that are known to provide clinical benefits show original
Breast cancer with HER2 overexpression as assessed by IHC (3+ or 2+ intensity score with positive FISH findings) or by gene expression analysis (GEA positive). show original
Any other HER2 IHC 3+ or FISH+ cancer
Patients in cohorts 5 and 6 must have a progression of their cancer after prior treatment with trastuzumab show original
and a taxane After prior treatment with trastuzumab and a taxane, patients with HER2-overexpressing (3+ by IHC) or HER2-2+ and FISH+ GEA must have progressed. show original

Patient Q&A Section

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

What are common treatments for her2-expressing cancers?

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Her2-expressing tumors, when analyzed by their expression of HER2, have significantly increased survival when treated with chemotherapy. For patients with HER2-positive breast carcinoma, HER2-targeted therapy can be used, but it does not significantly improve survival compared with chemotherapy.

Unverified Answer

Can her2-expressing cancers be cured?

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Breast cancer with a mutant HER2 gene (ie, a triple-negative (TNBC) cancer or a breast cancer with HER2 amplification, ie, an HER2-positive breast cancer) can be cureable.

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

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Findings from a recent study provides direct estimates of cancer incidence and prevalence as well as direct measurement of relative risk of developing Her2+ cancers, which are both of interest to cancer scientists and clinicians.

Unverified Answer

What causes her2-expressing cancers?

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Her2-expressing cancers do often not occur in people who have a mutation in Her2. The risk of these cancers is greatest in those that are BRCA-1/Her2 negative. Factors which reduce the risk for Her2 expression are probably many and varied in different cases of cancer, and are probably more related to the individual's lifestyle and environmental exposures than the Her2 or BRCA mutation in a given case of cancer.

Unverified Answer

What are the signs of her2-expressing cancers?

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Her2-3+ tumors are associated with lower survival, although this finding is a retrospective study of HER2 status in archived tissue and is not statistically significant. Other HER2-3+ cancers, such as oesophageal and gastro-oesophageal adenocarcinomas, show a more survival advantage.

Unverified Answer

What is her2-expressing cancers?

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Her2 expression is present in a wide array of malignant epithelial lesions in breast, ovarian and endometrial tissues, suggesting that Her2 expression may be a significant driver in progression of breast and ovarian cancers in individuals with BRCA1/2 predisposition.

Unverified Answer

What are the latest developments in zw25 (zanidatamab) for therapeutic use?

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When used in patients with [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer), antibody-dependent cellular cytotoxicity (ADCC) responses are observed. When used either in solid tumors like breast cancer or in hematologic malignancies, the most common side effects are grade 3-4 hypersensitivity reactions, fatigue, fever, gastrointestinal disturbances [diarrhea, abdominal pain], constipation"

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Unverified Answer

Have there been other clinical trials involving zw25 (zanidatamab)?

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As of March 2013, zw25 had not been given outside of the studies it was tested in. It did not receive FDA or EMA approval in any of these tests. For FDA approval, there are ~90 tests using zaritumab. You can find recent zaritumab trials by Power by using your specific disease condition, treatment, and country.

Unverified Answer

What does zw25 (zanidatamab) usually treat?

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For HER2+ cancers, the effectiveness of zanidatamab may have been overestimated in the published literature; however, the clinical efficacy of zanidatamab may still outweigh the drawbacks of its toxicity. The clinical course of these patients in response to zanidatamab, whether or not the drug was active, appears to be similar to that described elsewhere for trastuzumab, and may be further studied.

Unverified Answer

Is zw25 (zanidatamab) typically used in combination with any other treatments?

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ZA and other antibody therapies are typically used in combination with chemotherapy and/or biotherapy and have led to remarkable incremental survival in trials. ZA is typically used in combination with any other treatment type, such as platinum-based chemotherapy and/or biotechnology therapies.

Unverified Answer

Is zw25 (zanidatamab) safe for people?

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This open-label study indicates that zw25 is safe and well tolerated in people with advanced HER2-positive breast cancers. Zw25 appears to be safe and effective for treating metastatic HER2-positive breast cancers.

Unverified Answer

How does zw25 (zanidatamab) work?

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Taken together, these studies demonstrate that ZW25 has the capability to abrogate on-target and off-target antitumor activity. ZM2612 is not the only potential active moiety in ZW25. These data suggest that it remains to be determined whether ZW25 in combination with other therapeutics offers an effective therapeutic strategy for the treatment of solid tumors.

Unverified Answer
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Get access to this novel treatment for HER2-expressing Cancers by sharing your contact details with the study coordinator.