← Back to Search

Monoclonal Antibodies

Zanidatamab for Biliary Tract Cancer (HERIZON-BTC-01 Trial)

Phase 2
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically- or cytologically-confirmed BTC, including ICC, ECC or GBC.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks to 2.5 years
Awards & highlights

HERIZON-BTC-01 Trial Summary

This trial will study the effects of ZW25 monotherapy on subjects with HER2-amplified, inoperable and advanced or metastatic biliary tract cancer.

Who is the study for?
Adults with advanced or metastatic HER2-amplified biliary tract cancers, who've had prior gemcitabine chemotherapy but saw their disease progress or couldn't tolerate it. They must have good organ and heart function (ejection fraction ≥ 50%), no recent cancer treatments, no history of HER2-targeted therapy, controlled brain metastases if present, and no significant concurrent illnesses.Check my eligibility
What is being tested?
The trial is testing ZW25 (zanidatamab), a new medication targeting the HER2 protein in patients with specific types of biliary tract cancer that cannot be surgically removed. It's an open-label study where all participants receive the drug to see how well it works against their cancer.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to immune system activation such as infusion-related symptoms, allergic responses, fatigue, nausea or diarrhea. Organ-specific inflammation could also occur due to the targeted nature of zanidatamab.

HERIZON-BTC-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is a type of bile duct cancer confirmed by lab tests.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My bile duct cancer cannot be cured with surgery, transplant, or targeted therapies.
Select...
My heart pumps well, with an ejection fraction of 50% or higher.

HERIZON-BTC-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks to 2.5 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
Heart rate
Secondary outcome measures
DCR by investigator assessment
DOR at ≥ 16 weeks by ICR
DOR at ≥ 16 weeks by investigator assessment
+12 more

HERIZON-BTC-01 Trial Design

1Treatment groups
Experimental Treatment
Group I: ZW25 (Zanidatamab) MonotherapyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,272 Total Patients Enrolled
BeiGene, Ltd.UNKNOWN
2 Previous Clinical Trials
757 Total Patients Enrolled
Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,222 Total Patients Enrolled

Media Library

ZW25 (Zanidatamab) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04466891 — Phase 2
Biliary Tract Cancer Research Study Groups: ZW25 (Zanidatamab) Monotherapy
Biliary Tract Cancer Clinical Trial 2023: ZW25 (Zanidatamab) Highlights & Side Effects. Trial Name: NCT04466891 — Phase 2
ZW25 (Zanidatamab) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04466891 — Phase 2

Frequently Asked Questions

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

Is there still an opportunity for individuals to join this experimental research?

"This clinical trial is no longer open to enrollment. The initial advertisement was put out on October 1st 2020 and the listing was last updated September 15th 2022. If you are in search of new studies, there are presently 104 active trials seeking biliary tract cancer patients and 5 recruiting for ZW25 (Zanidatamab)."

Answered by AI

What potential harms could come to those taking Zanidatamab (ZW25)?

"A score of 2 is given to ZW25 (Zanidatamab) due to the lack of evidence regarding efficacy, though some preliminary data indicates a certain level of safety."

Answered by AI

How many participants have been accepted into this clinical trial thus far?

"This medical trial is not presently enrolling. It was first posted on October 1st 2020 and recently updated on September 15th 2022. For those interested in participating in a study, there are currently 104 studies seeking participants with biliary tract cancer and 5 trials recruiting for ZW25 (Zanidatamab)."

Answered by AI

In what geographic areas can participants access this experiment?

"Patients can be recruited from 17 different sites, a few of which include Pacific Hematology Oncology Associates - Clinic/Outpatient Facility in San Francisco, California, University of Arizona Cancer Center in Tucson, Arizona, and Washington University School of Medicine in Saint Louis, Missouri."

Answered by AI

Can you please summarize the previous examinations involving Zanidatamab (ZW25)?

"Zanidatamab (ZW25), first studied in the University of Ottawa in 2016, has had 0 completed trials to date. Nevertheless, there are currently 5 live studies being conducted with a prominent concentration at San Francisco's medical facilities."

Answered by AI

Are there any precedents for this pioneering clinical trial?

"Currently, there are 5 ongoing clinical trials for ZW25 (Zanidatamab) across 45 cities and 9 countries. Initially conducted in 2016 by Zymeworks Inc., the first trial enrolled a sample size of 279 participants and successfully reached its Phase 1 Drug Approval stage. Since then, no additional studies have been launched."

Answered by AI

Who else is applying?

What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried many other approaches and have had limited success. Hoping this will work for me and possibly help others with my condition. I’ve learned so much about this terrible disease, and can definitely help others with this knowledge.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
2020. "A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04466891.
~19 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top