What side effects are associated with this type of intervention?

Common treatments for Biliary Tract Cancer (BTC) include HER2 receptor inhibitors like zanidatamab, trastuzumab, and lapatinib. These treatments often cause side effects such as diarrhea, rash, and hepatic adverse events. Chemotherapy agents like gemcitabine and cisplatin are also frequently used and can lead to nausea, vomiting, myelosuppression, and nephrotoxicity. Newer agents like merestinib and silmitasertib have shown potential but also come with side effects such as fatigue, gastrointestinal disturbances, and hematologic toxicities. Patients should discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

As of now, there are limited FDA-approved treatments specifically targeting HER2 receptors in Biliary Tract Cancer (BTC). ZW25 (zanidatamab) is being studied for its efficacy in HER2-amplified BTC, which includes intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC). Broadly, treatments for BTC often include chemotherapy agents such as gemcitabine and cisplatin, and targeted therapies like FGFR inhibitors for specific genetic mutations. The development of HER2-targeted therapies like zanidatamab represents a promising area of research for BTC patients with HER2 amplification.

What other types of research exist?

Promising novel alternatives to ZW25 (zanidatamab) for Biliary Tract Cancer patients include: 1) Futibatinib, an irreversible FGFR1-4 inhibitor, which has shown significant activity in FGFR2 fusion/rearrangement-positive intrahepatic cholangiocarcinoma. 2) Silmitasertib, a casein kinase 2 inhibitor, combined with gemcitabine and cisplatin, which has demonstrated improved progression-free survival in advanced/metastatic cholangiocarcinoma.

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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.

Must not have

Received systemic anti-cancer therapy within 3 weeks of the first dose of ZW25. Received radiotherapy within 2 weeks of the first dose of ZW25.

Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks, up to 34 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called zanidatamab on patients with advanced biliary tract cancer that cannot be operated on. The drug targets a specific protein on cancer cells to help stop their growth and spread.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer treatment or radiotherapy in the last 3 weeks.

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I do not have severe pancreatitis or advanced liver disease.

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I am infected with HIV.

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I have active hepatitis.

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I have had a heart attack or severe heart issues in the last 6 months.

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I have been treated with drugs specifically for HER2 cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks, up to 34 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks, up to 34 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks, up to 34 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR)

Secondary study objectives

DCR by Investigator Assessment

DOR at ≥ 16 Weeks by ICR

DOR at ≥ 16 Weeks by Investigator Assessment

+11 more

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%

Pruritis

14%

Fatigue

14%

Hypokalemia

14%

Ejection fraction decreased

14%

Weight decreased

13%

Hypertension

11%

Blood bilirubin increased

Rash

Blood alkaline phosphatase increased

Dizziness

Abdominal pain upper

Hypoalbuminemia

Blood creatinine increased

Asthenia

Gamma-glutamyltransferase increased

Urinary tract infection

Dyspepsia

Oedema peripheral

Peripheral sesory neuropathy

Hypomagnesemia

Jaundice cholestatic

Constipation

Biliary obstruction

Sepsis

Ascites

Pneumonia

Platelet count decreased

Drug hypersensitivity

Hyponatremia

Obstruction gastric

Cholangitis

Epistaxis

Jaundice

Bacteremia

Cholangitis infective

Oral candidiasis

Ileus

Duodenal ulcer

Feces discolored

Paraneoplastic syndrome

Gastric ulcer

Hypochloraemia

Device related infection

COVID-19

Hemangioma

Small intestinal obstruction

Biliary tract infection

Pleural effusion

Pneumonitis

Pneumothorax

Cholangiocarcinoma

Acute kidney injury

Hypoproteinemia

Abdominal lymphadenopathy

Liver abscess

Duodenal obstruction

Bile duct stenosis

Cholecystitis

Hepatic failure

Pseudomembranous colitis

Duodenal stenosis

Enteritis

Haematemesis

Large intestinal obstruction

Pancreatitis

Upper gastrointestinal hemorrhage

Cerebrovascular accident

Syncope

Malnutrition

Aortic aneurysm

Procedural pain

Pollakiuria

100%

80%

60%

40%

20%

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) MonotherapyExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ZW25 (Zanidatamab)

2016

Completed Phase 2

~370

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Biliary Tract Cancer (BTC) include targeted therapies, chemotherapy, and immunotherapy. ZW25 (zanidatamab) is a monoclonal antibody that targets the HER2 receptor, which is overexpressed in some BTCs. By binding to HER2, zanidatamab inhibits tumor growth and survival. This is crucial for BTC patients as HER2 amplification is associated with aggressive disease and poor prognosis. Other treatments include chemotherapy agents like gemcitabine and oxaliplatin, which kill rapidly dividing cancer cells, and immunotherapies such as pembrolizumab, which enhance the immune system's ability to fight cancer. These treatments offer hope for improved outcomes in a disease that is often diagnosed at an advanced stage.

Dramatic response to dabrafenib and trametinib combination in a BRAF V600E-mutated cholangiocarcinoma: implementation of a molecular tumour board and next-generation sequencing for personalized medicine.Combining biological agents and chemotherapy in the treatment of cholangiocarcinoma.Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study.