ZW49 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ZW49, an experimental drug, to determine the best dose and assess its safety for individuals with certain types of cancer. It targets cancers with high levels of HER2, a protein influencing cancer growth, including breast cancer and gastroesophageal adenocarcinoma. Participants should have advanced cancer that has not responded to standard treatments like trastuzumab or pertuzumab. Those with HER2-high cancer that continues to progress despite these treatments may be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the ZW49 trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that ZW49 is likely to be safe for humans?
Research has shown that ZW49, the treatment being tested, has potential for safety based on earlier studies. These studies examined ZW49's safety and its effectiveness against tumors. The results suggest that its side effects are manageable, meaning they are acceptable when considering the possible benefits.
Researchers have tested ZW49 at different doses and identified a recommended dose based on safety information. While some side effects might occur, they are usually not severe enough to stop the treatment. Notably, these studies included patients who had tried other treatments without success. Since ZW49 is being tested in a Phase 1 study, the safety evaluation remains in the early stages.
In summary, although ZW49 is still under study, the safety data so far are promising. The treatment appears well-tolerated, and any side effects have been manageable.12345Why do researchers think this study treatment might be promising?
ZW49 is unique because it uses an antibody-drug conjugate (ADC) approach, which combines an antibody that specifically targets cancer cells with a powerful chemotherapy drug. Unlike traditional treatments like chemotherapy or radiation, which affect both healthy and cancerous cells, ZW49 is designed to deliver the drug directly to the cancer cells, minimizing damage to healthy tissue. Researchers are excited about ZW49 because it has the potential to improve efficacy while reducing side effects, offering a more targeted and potentially safer treatment option for cancer patients.
What evidence suggests that ZW49 might be an effective treatment for HER2-expressing cancers?
Research has shown that ZW49 may help treat cancers with the HER2 protein. In earlier studies, patients with HER2+ cancers who had already received many treatments experienced a 100% disease control rate, meaning their cancer stopped growing. Some patients also saw their tumors shrink. Although these results are early, they suggest that ZW49 might help stop cancer growth and reduce tumor size in some patients. This treatment remains under study in this trial, so more information is needed to confirm these findings.23678
Who Is on the Research Team?
Joseph Woolery, PharmD, BCOP
Principal Investigator
Zymeworks BC Inc.
Are You a Good Fit for This Trial?
This trial is for patients with advanced HER2-positive cancers, including breast cancer and gastroesophageal adenocarcinoma (GEA), who have tried standard treatments without success or cannot tolerate them. Participants must have a confirmed diagnosis, measurable disease for certain cohorts, an ECOG performance status of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and adequate organ function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
3+3 dose-escalation study design to evaluate the safety and tolerability of ZW49 and determine the MTD or RD
Expansion Cohorts
Selected expansion cohorts to further evaluate the safety and tolerability of ZW49 at the MTD or RD and assess preliminary anti-tumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ZW49
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zymeworks BC Inc.
Lead Sponsor
Zymeworks Inc.
Lead Sponsor