← Back to Search
Monoclonal Antibodies
ZW25 + Chemotherapy for Advanced Cancer
San Antonio, TX
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 belowSelect...
My cancer is HER2 positive and has worsened after trastuzumab treatment.
Select...
My colorectal cancer is KRAS wild-type.
Select...
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.
Select...
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.
Select...
My cancer is HER2 positive, confirmed by tests.
Select...
This criterion is incomplete.
Select...
My breast cancer is HER2 low and I've had 1-3 chemotherapy treatments.
Select...
My breast cancer is HER2 positive and I've had specific treatments but no more than 3 chemotherapy regimens.
Select...
My cancer is HER2 positive and I've had 1-3 chemotherapy treatments.
Select...
I have HER2 positive cancer and have been treated with trastuzumab.
Select...
I have HER2-positive breast cancer and have 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.
Select...
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.
Select...
I am 18 years old or older.
Select...
My heart's left ventricle functions well, meeting the normal standards.
Select...
I can provide a sample of my tumor.
Select...
This information is part of a larger set of criteria.
Select...
My NSCLC lacks ALK, EGFR mutations, and ROS1 fusion.
Select...
My cancer is HER2 positive and has worsened after treatment with trastuzumab.
Select...
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.
Select...
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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2024 Phase 2 trial • 87 Patients • NCT0446689149%
Diarrhea
34%
Infusion related reaction
23%
Anemia
20%
Alanine aminotransferase increased
19%
Abdominal pain
19%
Aspartate aminotransferase increased
18%
Nausea
16%
Pyrexia
16%
Decreased appetite
15%
Vomiting
14%
Fatigue
14%
Weight decreased
14%
Pruritis
14%
Ejection fraction decreased
14%
Hypokalemia
13%
Hypertension
11%
Blood bilirubin increased
9%
Blood alkaline phosphatase increased
9%
Rash
9%
Dizziness
9%
Abdominal pain upper
8%
Asthenia
8%
Urinary tract infection
8%
Blood creatinine increased
8%
Hypoalbuminemia
8%
Gamma-glutamyltransferase increased
6%
Jaundice cholestatic
6%
Oedema peripheral
6%
Dyspepsia
6%
Peripheral sesory neuropathy
6%
Constipation
6%
Hypomagnesemia
5%
Pneumonia
5%
Sepsis
5%
Biliary obstruction
5%
Ascites
4%
Cholangitis
4%
Platelet count decreased
4%
Obstruction gastric
4%
Drug hypersensitivity
4%
Hyponatremia
3%
Jaundice
3%
Epistaxis
3%
Bacteremia
1%
Enteritis
1%
Feces discolored
1%
Pancreatitis
1%
Small intestinal obstruction
1%
Hepatic failure
1%
Cholecystitis
1%
Gastric ulcer
1%
Haematemesis
1%
Ileus
1%
Large intestinal obstruction
1%
Upper gastrointestinal hemorrhage
1%
Pleural effusion
1%
Pneumonitis
1%
Pneumothorax
1%
Cholangiocarcinoma
1%
Hemangioma
1%
Paraneoplastic syndrome
1%
Cerebrovascular accident
1%
Syncope
1%
Malnutrition
1%
Acute kidney injury
1%
Aortic aneurysm
1%
Procedural pain
1%
Hypoproteinemia
1%
Device related infection
1%
Duodenal stenosis
1%
Pseudomembranous colitis
1%
Duodenal obstruction
1%
Abdominal lymphadenopathy
1%
Duodenal ulcer
1%
Hypochloraemia
1%
Pollakiuria
1%
Bile duct stenosis
1%
Biliary tract infection
1%
COVID-19
1%
Cholangitis infective
1%
Liver abscess
1%
Oral candidiasis
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
Tucatinib
2017
Completed Phase 2
~800
Vinorelbine
2013
Completed Phase 4
~2190
Paclitaxel
2011
Completed Phase 4
~5450
Capecitabine
2013
Completed Phase 3
~4280
Find a Location
Closest Location:South Texas Accelerated Research Therapeutics (START)· San Antonio, TX
Who is running the clinical trial?
Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,130 Total Patients Enrolled
Jazz PharmaceuticalsLead Sponsor
251 Previous Clinical Trials
34,771 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.