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.
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.
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.
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.
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.
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.
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.
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"
"Banksia dallanneyi subsp. chamaecephala\n\nBanksia dallanneyi" subsp. "chamaecephala is a subspecies of "Banksia dallanneyi", endemic to Western Australia.
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.
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.
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.
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.
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.