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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
Must not have
Treatment with other cancer therapy not otherwise specified within 4 weeks before ZW25 dosing
Trastuzumab, pertuzumab, lapatinib, or T-DM1 within 3 weeks before first ZW25 dosing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My cancer is HER2 positive and has worsened after trastuzumab treatment.
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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.
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My cancer expresses the HER2 protein.
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My cancer is advanced, cannot be surgically removed, and has worsened despite treatment.
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I am fully active or can carry out light work.
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My cancer is HER2 IHC 2+ and FISH-.
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My cancer is HER2 IHC 2+ /FISH- in breast or gastroesophageal.
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My cancer is HER2 positive.
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My cancer is HER2 positive based on specific tests.
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My breast cancer is HER2-positive, confirmed by tests.
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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.
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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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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.
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My cancer has not spread to my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had any cancer treatment in the last 4 weeks.
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I haven't taken cancer drugs like Trastuzumab or similar in the last 3 weeks.
Select...
I haven't had anthracyclines in the last 90 days or exceeded the lifetime limit.
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I have not taken capecitabine or fam-trastuzumab deruxtecan-nxki for metastatic disease.
Select...
This criterion seems incomplete. Please provide more details.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 2 trial • 87 Patients • NCT04466891
49%
Diarrhea
34%
Infusion related reaction
23%
Anemia
20%
Alanine aminotransferase increased
19%
Aspartate aminotransferase increased
19%
Abdominal pain
18%
Nausea
16%
Decreased appetite
16%
Pyrexia
15%
Vomiting
14%
Ejection fraction decreased
14%
Weight decreased
14%
Pruritis
14%
Fatigue
14%
Hypokalemia
13%
Hypertension
11%
Blood bilirubin increased
9%
Abdominal pain upper
9%
Rash
9%
Blood alkaline phosphatase increased
9%
Dizziness
8%
Hypoalbuminemia
8%
Blood creatinine increased
8%
Asthenia
8%
Gamma-glutamyltransferase increased
8%
Urinary tract infection
6%
Constipation
6%
Oedema peripheral
6%
Dyspepsia
6%
Peripheral sesory neuropathy
6%
Hypomagnesemia
6%
Jaundice cholestatic
5%
Biliary obstruction
5%
Sepsis
5%
Ascites
5%
Pneumonia
4%
Obstruction gastric
4%
Platelet count decreased
4%
Drug hypersensitivity
4%
Hyponatremia
4%
Cholangitis
3%
Epistaxis
3%
Jaundice
3%
Bacteremia
1%
Cholangitis infective
1%
Duodenal ulcer
1%
Feces discolored
1%
Cholecystitis
1%
Syncope
1%
Oral candidiasis
1%
Gastric ulcer
1%
Duodenal obstruction
1%
Ileus
1%
Device related infection
1%
Haematemesis
1%
Cerebrovascular accident
1%
Paraneoplastic syndrome
1%
COVID-19
1%
Hypochloraemia
1%
Liver abscess
1%
Malnutrition
1%
Bile duct stenosis
1%
Hepatic failure
1%
Pollakiuria
1%
Hemangioma
1%
Upper gastrointestinal hemorrhage
1%
Cholangiocarcinoma
1%
Small intestinal obstruction
1%
Biliary tract infection
1%
Pleural effusion
1%
Pneumonitis
1%
Pneumothorax
1%
Acute kidney injury
1%
Hypoproteinemia
1%
Abdominal lymphadenopathy
1%
Pseudomembranous colitis
1%
Duodenal stenosis
1%
Enteritis
1%
Large intestinal obstruction
1%
Pancreatitis
1%
Aortic aneurysm
1%
Procedural pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort I
Cohort II

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
ZW25 (Zanidatamab)
2016
Completed Phase 2
~370
Vinorelbine
2013
Completed Phase 4
~2190
Tucatinib
2017
Completed Phase 2
~800
Paclitaxel
2011
Completed Phase 4
~5450
Capecitabine
2013
Completed Phase 3
~4280

Find a Location

Who is running the clinical trial?

Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,192 Total Patients Enrolled
Jazz PharmaceuticalsLead Sponsor
251 Previous Clinical Trials
34,755 Total Patients Enrolled
Rajen Oza, MD, MBAStudy DirectorZymeworks Inc.

Media Library

ZW25 (Zanidatamab) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02892123 — Phase 1
Cancer Research Study Groups: ZW25 (Zanidatamab) Monotherapy and ZW25 Combination Therapy
Cancer Clinical Trial 2023: ZW25 (Zanidatamab) Highlights & Side Effects. Trial Name: NCT02892123 — Phase 1
ZW25 (Zanidatamab) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02892123 — Phase 1
~30 spots leftby Jan 2026
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