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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
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My cancer is a type of bile duct cancer confirmed by lab tests.
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I am fully active and can carry on all pre-disease activities without restriction.
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My bile duct cancer cannot be cured with surgery, transplant, or targeted therapies.
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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
34,262 Total Patients Enrolled
BeiGene, Ltd.UNKNOWN
2 Previous Clinical Trials
961 Total Patients Enrolled
Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,385 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
~19 spots leftby May 2025
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