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Monoclonal Antibodies
ZW25 + Chemotherapy for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Zymeworks Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- HER2-overexpressing (3+ by IHC) or HER2-2+ and FISH+ GEA must have progressed after prior treatment with trastuzumab
- Patients with colorectal cancer must be KRAS wild-type
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the duration of the study; up to 2 years
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of the drug ZW25, either by itself or combined with chemotherapy, in patients with HER2-expressing cancers that are locally advanced or have spread to other parts of the body. The trial will also evaluate how the body absorbs, distributes, and eliminates ZW25.
Who is the study for?
Adults with advanced HER2-expressing cancers, including breast and gastroesophageal adenocarcinoma (GEA), who have tried certain treatments like trastuzumab without success. They should be in good overall health with a life expectancy of at least 3 months and have cancer that can be measured by scans. Pregnant or breastfeeding women and those with recent other cancer therapies or severe allergies to monoclonal antibodies are excluded.Check my eligibility
What is being tested?
The trial is testing ZW25 (zanidatamab) alone or combined with chemotherapy drugs such as Paclitaxel, Capecitabine, Vinorelbine, Tucatinib to see how safe and effective they are against HER2-positive cancers. The study will also look into how the body processes ZW25.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system due to monoclonal antibody treatment, typical chemotherapy-related issues like nausea, fatigue, hair loss, nerve damage (neuropathy), and an increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is HER2 positive and has worsened after trastuzumab treatment.
Select...
My colorectal cancer is KRAS wild-type.
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My HER2+ breast cancer has worsened despite treatment with trastuzumab, pertuzumab, and T-DM1.
Select...
My cancer expresses the HER2 protein.
Select...
My cancer is advanced, cannot be surgically removed, and has worsened despite treatment.
Select...
I am fully active or can carry out light work.
Select...
My cancer is HER2 IHC 2+ and FISH-.
Select...
My cancer is HER2 IHC 2+ /FISH- in breast or gastroesophageal.
Select...
My cancer is HER2 positive.
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My cancer is HER2 positive based on specific tests.
Select...
My breast cancer is HER2-positive, confirmed by tests.
Select...
My cancer is HER2 positive, confirmed by specific tests.
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My cancer is HER2 positive, confirmed by tests.
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This criterion is incomplete.
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My breast cancer is HER2 low and I've had 1-3 chemotherapy treatments.
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My breast cancer is HER2 positive and I've had specific treatments but no more than 3 chemotherapy regimens.
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My cancer is HER2 positive and I've had 1-3 chemotherapy treatments.
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I have HER2 positive cancer and have been treated with trastuzumab.
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I have HER2-positive breast cancer and have been treated with trastuzumab, pertuzumab, and T-DM1.
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My breast cancer is HER2 positive and I've been treated with trastuzumab, pertuzumab, and T-DM1.
Select...
My breast cancer is HER2-positive and I've been treated with trastuzumab, pertuzumab, and T-DM1.
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My breast cancer is HER2-positive and I've been treated with trastuzumab, pertuzumab, and T-DM1.
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I am 18 years old or older.
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My heart's left ventricle functions well, meeting the normal standards.
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I can provide a sample of my tumor.
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This information is part of a larger set of criteria.
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My NSCLC lacks ALK, EGFR mutations, and ROS1 fusion.
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My cancer is HER2 positive and has worsened after treatment with trastuzumab.
Select...
My cancer has not spread to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the duration of the study; up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the duration of the study; up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of patients who experience dose-limiting toxicities (DLTs) (Part 1)
The proportion patients who experience laboratory abnormalities and/or adverse events as defined by CTCAE v4.03 that are related to treatment (Parts 2 and 3)
Secondary outcome measures
Progression free survival as defined by RECIST 1.1 criteria
Serum concentrations of ZW25
The proportion of patients who develop detectable anti-drug antibodies
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ZW25 (Zanidatamab) Monotherapy and ZW25 Combination TherapyExperimental Treatment5 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Capecitabine
2013
Completed Phase 3
~3420
Vinorelbine
2013
Completed Phase 4
~2190
Tucatinib
2017
Completed Phase 2
~520
Find a Location
Who is running the clinical trial?
Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,030 Total Patients Enrolled
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,080 Total Patients Enrolled
Rajen Oza, MD, MBAStudy DirectorZymeworks Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received any experimental treatments within 4 weeks before starting the ZW25 medication.My cancer is HER2 positive and has worsened after trastuzumab treatment.My colorectal cancer is KRAS wild-type.I haven't had any cancer treatment in the last 4 weeks.My HER2+ breast cancer has worsened despite treatment with trastuzumab, pertuzumab, and T-DM1.My cancer expresses the HER2 protein.My cancer is advanced, cannot be surgically removed, and has worsened despite treatment.I am fully active or can carry out light work.My cancer is HER2 IHC 2+ and FISH-.I haven't taken cancer drugs like Trastuzumab or similar in the last 3 weeks.I have never been treated with taxanes.I haven't had anthracyclines in the last 90 days or exceeded the lifetime limit.I have not taken capecitabine or fam-trastuzumab deruxtecan-nxki for metastatic disease.I do not have uncontrolled kidney, pancreas, or liver issues, except for allowed conditions.My cancer is HER2 IHC 2+ /FISH- in breast or gastroesophageal.My cancer is HER2 positive.My breast cancer is HER2 positive and I've been treated with trastuzumab, pertuzumab, and T-DM1.My breast cancer is HER2-positive and I've been treated with trastuzumab, pertuzumab, and T-DM1.My breast cancer is HER2-positive and I've been treated with trastuzumab, pertuzumab, and T-DM1.My cancer is HER2 positive, confirmed by specific tests.My cancer is HER2 positive, confirmed by tests.My cancer cannot be removed by surgery and/or has spread to other parts of my body.My breast cancer is HER2 low and I've had 1-3 chemotherapy treatments.My breast cancer is HER2 positive and I've had specific treatments but no more than 3 chemotherapy regimens.My cancer is HER2 positive and I've had 1-3 chemotherapy treatments.My cancer is HER2 positive based on specific tests.My HER2 positive breast cancer has worsened despite previous treatments.My breast cancer is HER2-positive, confirmed by tests.My GI cancer is HER2 positive and, if it's colorectal, it's KRAS wild-type.My cancer is HER2 positive and not breast or GI cancer. It meets specific genetic criteria.This criterion is incomplete.I am 18 years old or older.My heart's left ventricle functions well, meeting the normal standards.My cancer can be measured or evaluated using specific criteria.I can provide a sample of my tumor.I have brain metastases that do not require immediate treatment.I have HER2 positive cancer and have been treated with trastuzumab.I have HER2-positive breast cancer and have been treated with trastuzumab, pertuzumab, and T-DM1.This criterion requires more context to provide a summary.My brain metastases are stable or have progressed but don't need immediate treatment.You have had a severe allergic reaction to monoclonal antibodies or other ingredients in the study drug.I have treated brain metastases and have been stable without steroids for over a month.My cancer is advanced, cannot be surgically removed, and has worsened after all known beneficial treatments.This information is part of a larger set of criteria.My organs are working well.My NSCLC lacks ALK, EGFR mutations, and ROS1 fusion.My cancer is HER2 positive and has worsened after treatment with trastuzumab.My breast cancer is HER2 2+ and FISH-.My cancer has not spread to my brain.This criterion seems incomplete. Please provide more details.
Research Study Groups:
This trial has the following groups:- Group 1: ZW25 (Zanidatamab) Monotherapy and ZW25 Combination Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Zanidatamab (ZW25) for public use?
"The safety of Zanidatamab (ZW25) is estimated to be a score of 1 since this Phase 1 trial has minimal data indicating efficacy or patient protection."
Answered by AI
What is the main indication of ZW25 (Zanidatamab)?
"ZW25 (Zanidatamab) has been clinically proven to be a viable treatment for those with previously untreated neoplasm metastasis and soft tissue sarcoma (STS)."
Answered by AI
Is recruitment for this clinical research currently open?
"This study is no longer accepting enrolment. It was first listed on September 1st 2016 and saw its last update 28th of October 2022. If you are interested in getting involved with a clinical trial, there are 3 studies for the erbb-2 receptor presently recruiting as well as 1173 trials involving Zanidatamab that are actively seeking participants."
Answered by AI
Is there a precedent of successful experimentation with Zanidatamab (ZW25)?
"As of now, the research concerning ZW25 (Zanidatamab) has yielded 1173 studies; 355 are in Phase 3. Though Guangzhou, Guangdong is home to many trials for this medication, 61171 sites around the world currently have active clinical trials related to it."
Answered by AI
What is the geographic scope of this scientific experiment?
"This research initiative is presently being conducted across 11 sites, including Newport Beach, Aurora and Houston. To minimise travel demands for the participants, it may be prudent to select the closest clinic you can find."
Answered by AI
How many participants are engaging in this experiment?
"Unfortunately, no more participants are being accepted for this trial. It was originally posted on September 1st 2016 and edited as of October 28th 2022. If you're searching for other studies to join, there 3 clinical trials recruiting patients with erbb-2 receptor mutations and 1173 active trials seeking individuals to test Zanidatamab (ZW25)."
Answered by AI
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