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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new drug, ZW49, to see what dose is safe for people with HER2-positive cancer. The trial is open-label, meaning participants will know they are receiving the study drug.

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.Check my eligibility
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.See study design
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.
Select...
I am fully active or can carry out light work.
Select...
My cancer is advanced and cannot be removed by surgery.
Select...
My cancer is HER2-high and advanced.
Select...
My heart's left ventricle functions well.
Select...
I have HER2-high stomach cancer and was treated with trastuzumab.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Incidence of dose reductions of ZW49
Incidence of dose-limiting toxicities (DLTs)
+2 more
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Zymeworks BC Inc.Lead Sponsor
3 Previous Clinical Trials
837 Total Patients Enrolled
Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,135 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

Frequently Asked Questions

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

What is the upper limit for participants in this experiment?

"Zymeworks Inc., the sponsor of this trial, requires a total of 174 patients that meet certain criteria in order to start. The study will be conducted at Stanford University School of Medicine and NEXT Oncology, both located in California and Texas respectively."

Answered by AI

Has the FDA granted authorization to ZW49?

"ZW49's safety is rated 1 due to being in the initial phase of patient testing, meaning there are just a few data points which have been collected regarding its successful use and security."

Answered by AI

What are the proposed positive results of this research?

"According to the reports from Zymeworks Inc., the primary endpoint for this trial will be measured over a period of 7 months and focus on ECG and LVEF abnormalities. Additionally, secondary outcome variables such as median overall survival (in months) with corresponding range (minimum-maximum), end of infusion concentration, maximum serum concentration, and trough concentration of ZW49, plus number of participants who develop ADAs are also being examined."

Answered by AI

How many sites are hosting this clinical research?

"11 research institutions are participating in this trial, such as Stanford University School of Medicine (Palo Alto), NEXT Oncology (San Antonio), and Sarah Cannon Research Institute (Nashville). Other locations have also been approved."

Answered by AI

Is recruitment for this medical experiment still open?

"Based on clinicaltrials.gov, this research is still actively seeking participants for its study. It was first published in April 2019 and the latest changes were made to it in November 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers
2019. "A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03821233.
~35 spots leftby Aug 2025
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