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Monoclonal Antibodies

ZW49 for Cancer

Phase 1
Waitlist Available
Research Sponsored by Zymeworks BC Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with HER2-high breast cancer must have received prior treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1)
ECOG performance status score of 0 or 1
Must not have
Known history of human immunodeficiency virus (HIV) infection
Clinically significant infiltrative pulmonary disease not related to lung metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing ZW49, a new drug, to find the safest and most effective dose. It focuses on patients with advanced or metastatic HER2-positive cancers. The drug works by targeting and destroying cancer cells marked by the HER2 protein.

Who is the study for?
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.
What is being tested?
The study is testing ZW49 to find the highest dose patients can take without severe side effects (MTD) and to see how safe it is. It's open-label so everyone knows they're getting ZW49, and it starts by giving small doses that get bigger until they find the MTD or recommended dosage.
What are the potential side effects?
While specific side effects of ZW49 aren't listed here as this is a first-in-human study determining safety, common side effects from similar cancer drugs include nausea, fatigue, infusion reactions like fever or chills, diarrhea, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have HER2-high breast cancer and was treated with trastuzumab, pertuzumab, and T-DM1.
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I am fully active or can carry out light work.
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My cancer is advanced and cannot be removed by surgery.
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My cancer is HER2-high and advanced.
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My heart's left ventricle functions well.
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I have HER2-high stomach cancer and was treated with trastuzumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with HIV.
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I have a serious lung condition not caused by cancer spread.
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I haven't had a heart attack, unstable chest pain, or serious heart issues in the last 6 months.
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I have been diagnosed with leptomeningeal disease.
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I have an active hepatitis B or C infection or another chronic liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Incidence of dose reductions of ZW49
Incidence of dose-limiting toxicities (DLTs)
+2 more
Secondary study objectives
Disease control rate
Duration of response
Incidence of anti-drug antibodies (ADAs)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ZW49Experimental Treatment1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
HER2-targeted therapies, such as the investigational agent ZW49, work by binding to the HER2 receptors on cancer cells, which are overexpressed in certain cancers like breast and gastric cancers. This binding inhibits cell proliferation and survival pathways, leading to cancer cell death. This targeted approach is significant for cancer patients as it offers a more precise treatment option, potentially reducing tumor growth and spread while minimizing damage to normal cells, thereby improving therapeutic outcomes and reducing side effects.
Current trends and future directions in the genetic therapy of human neoplastic disease.New molecular targets in malignant gliomas.

Find a Location

Who is running the clinical trial?

Zymeworks BC Inc.Lead Sponsor
5 Previous Clinical Trials
1,142 Total Patients Enrolled
Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,298 Total Patients Enrolled
Joseph Woolery, PharmD, BCOPStudy DirectorZymeworks BC Inc.
3 Previous Clinical Trials
128 Total Patients Enrolled

Media Library

ZW49 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03821233 — Phase 1
~23 spots leftby Aug 2025
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