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Chemotherapy

Zanidatamab + Standard Therapy for Biliary Tract Cancer

Phase 3

Recruiting

Research Sponsored by Jazz Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) by IHC and in situ Hybridization (ISH) assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy

Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment

Must not have

Severe chronic or active infections

Females who are breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 68 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to test the effectiveness and safety of a combination of drugs called Zanidatamab and CisGem, with or without another drug called a PD-1/L1 inhibitor,

Who is the study for?

This trial is for adults with advanced HER2-positive biliary tract cancer. Participants should be starting their first treatment and can handle chemotherapy. They must not have had previous treatments that target the PD-1/L1 pathways or therapies specifically for HER2.

What is being tested?

The study tests Zanidatamab combined with Cisplatin and Gemcitabine (CisGem), with an optional addition of a PD-1/L1 inhibitor (Durvalumab or Pembrolizumab). It's to see if this mix works better as a first-line treatment compared to just CisGem.

What are the potential side effects?

Possible side effects include allergic reactions, blood cell count changes, kidney damage from Cisplatin; fever, flu-like symptoms from Gemcitabine; immune-related issues like lung inflammation from Durvalumab/Pembrolizumab; and infusion reactions from Zanidatamab.

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 based on specific lab tests.

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My cancer's growth can be tracked using specific criteria.

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My bile duct cancer cannot be removed by surgery and is not eligible for curative treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am willing to use two forms of birth control if I or my partner can have children.

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My cancer is confirmed as Biliary Tract Cancer, including Gallbladder or Cholangiocarcinoma.

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I've had up to 2 treatments with specific drugs for my advanced cancer.

Exclusion Criteria

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

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I have a severe ongoing infection.

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I am currently breastfeeding.

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I have been treated with a HER2-targeted therapy before.

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My bile duct cancer is not one of the excluded types like small cell or neuroendocrine.

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I have been treated with immune checkpoint inhibitors, but not durvalumab or pembrolizumab.

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I am currently taking corticosteroids.

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My cancer has spread to my brain.

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I have had lung conditions not caused by infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 68 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 68 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 68 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

Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors

Secondary study objectives

Duration of response (DOR)

Number of participants achieving Confirmed objective response rate (cORR)

OS for all participants

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Zanidatamab with Standard-of-care Therapy ArmExperimental Treatment5 Interventions

Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.

Group II: Standard-of-care Therapy ArmActive Control4 Interventions

Standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Durvalumab

2017

Completed Phase 2

~3750