ZW49 for HER2-expressing Cancers

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Chicago Medicine, Chicago, IL
ZW49 - 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

Study Objectives

This trial is evaluating whether ZW49 will improve 5 primary outcomes and 7 secondary outcomes in patients with HER2-expressing Cancers. Measurement will happen over the course of Up to 4 weeks.

Up to 2 years
Duration of response
Overall survival
Progression-free survival
Up to 4 weeks
Incidence of dose-limiting toxicities (DLTs)
Up to 6 months
Disease control rate
Objective response rate (ORR)
Up to 7 months
Incidence of adverse events
Incidence of anti-drug antibodies (ADAs)
Incidence of dose reductions of ZW49
Incidence of electrocardiogram (ECG) and left ventricular ejection fraction (LVEF) abnormalities
Incidence of lab abnormalities
Serum concentrations of ZW49

Trial Safety

Trial Design

2 Treatment Groups

Control
ZW49

This trial requires 174 total participants across 2 different treatment groups

This trial involves 2 different treatments. ZW49 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.

ZW49
Drug
ControlNo treatment in the control group

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

University of Chicago Medicine - Chicago, IL

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:
Expansion (Cohort 2): HER2-high breast cancer
Expansion (Cohort 3): HER2-high GEA
Progressive disease that has progressed on or been refractory to all standard of care. Patients who were intolerant to or ineligible for standard therapy may be eligible if the reasons are carefully documented and approval is provided by the sponsor medical monitor Patients with HER2-high breast cancer must have received prior treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1)
Patients with HER2-high GEA must have received prior treatment with trastuzumab
Sites of disease assessible per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Pathologically-confirmed diagnosis of breast cancer, gastroesophageal adenocarcinoma (GEA), or other HER2-expressing cancer with evidence of locally advanced (unresectable) and/or metastatic disease.
Dose-escalation (Cohort 1): HER2-high advanced solid tumors
Expansion (Cohort 4): HER2-high other non-breast and non-GEA cancers
Dose-escalation: measurable or non-measurable disease
Expansion: measurable disease

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 the signs of her2-expressing cancers?

Add answer

The most common presenting signs in this population of patients with HER2-positive metastatic breast cancer are unexplained weight loss, bone pain, and pain in the primary tumor site. Findings from a recent study support the inclusion of chemotherapy for these patients with symptomatic HER2-positive metastatic breast cancer.

Unverified Answer

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

Add answer

around 16.2 million American women and 2.7 million American men get breast cancer. About 12.1 million women and 2.0 million men get colorectal cancer. About 10.1 million women and 1.3 million men get prostate cancer. The remainder gets some form of non-melanoma skin cancer. About 8.6 million women get ovarian cancer. About 5.4 million women and 1.5 million men get lung cancer. About 3.6 million women and 1.0 million men get non-Hodgkin's lymphoma. About 1.6 million women and 0.8 million men get other types of breast cancer. About 0.6 million women and 0.

Unverified Answer

What is her2-expressing cancers?

Add answer

Clinically, HER2 is an integral component of human cancers. HER2 has been implicated in the development and growth of breast cancer, and thus plays an important role in the therapy of breast cancer.

Unverified Answer

What causes her2-expressing cancers?

Add answer

We have shown that HER2 has an important role in breast cancer progression, metastasis and tumor maintenance, and that HER2-positive/negative phenotyping in primary breast cancer is highly predictive regardless of estrogen receptor (ER) status.

Unverified Answer

What are common treatments for her2-expressing cancers?

Add answer

The management of HER2-expressing breast cancer patients appears to differ significantly from common treatments for non-HER2-expressing breast cancer. Patients with HER2-expressing breast cancers may not benefit from treatment with trastuzumab at adjuvant systemic therapy, or if in fact, as many as 30% of patients in this group are not "responders" to trastuzumab, given concurrently with paclitaxel and carboplatin.

Unverified Answer

Can her2-expressing cancers be cured?

Add answer

Given the success rate of surgery to remove tumors from women treated with the AHSG and RTLN protocols, women with breast and/or lymph node ErbB2+ tumors should generally be cured with the current standard of care. However, for men with locally invasive ErbB2+ advanced prostate cancer, surgery is probably not curative.

Unverified Answer

What are the latest developments in zw49 for therapeutic use?

Add answer

Zw49 may offer additional benefit over standard therapy in some cases of advanced HER2+ breast cancer, as well as possible adjuvant therapies and adjuvant therapies used in the early stages of breast cancer treatment. However, the data presented in this paper must be interpreted with caution and further validation in other clinical settings is required.

Unverified Answer

What does zw49 usually treat?

Add answer

The Zw49-mediated apoptosis results in death of both proliferating and clonogenic tumor cells, which indicates that Zw49 exerts cell-growth inhibition or proliferation inhibition independently of EGFR.

Unverified Answer

What is zw49?

Add answer

Zw49 has been shown to play the role of tumor suppressor in human cancer cells. In addition, recent findings suggest that Zw49 is a regulator of the HER2/neu proto-oncogene. There are a few studies indicating that the Zw49 protein level is decreased in HER2 positive breast cancer tissue, thereby confirming the importance of Zw49 as a tumor suppressor protein in breast cancer. It can be assumed that epigenetics plays a pivotal role in decreasing the Zw49 protein expression, thereby causing abnormal proliferation of the cells.

Unverified Answer

What is the primary cause of her2-expressing cancers?

Add answer

Her2-expressing cancers are most commonly associated with ER negativity in luminal A tumors; however, when ER negativity is not the only risk factor, a combination of other risk factors often results in Her2 expression in luminal A tumors.

Unverified Answer

How does zw49 work?

Add answer

Findings from a recent study indicate that Zw49 is primarily responsible for the regulation of DNA methylation. We found that in addition to histone acetylation and deacetylation, Zw49 has a novel role in the repression or induction of the DNA methyltransferase gene, DNMT1. DNA methylation by DNMT1 is responsible for the silencing of target genes including the p16(INK4a) and/or RASSF1A tumor suppressors.

Unverified Answer

Have there been other clinical trials involving zw49?

Add answer

There has been a growing number of clinical trials that are using the zw49 gene as a target and all of these trials are using different dosing schedules and protocols to treat the cancers. power has been involved in every one of these clinical trials as a partner.

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