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Chemotherapy

Zanidatamab with Standard-of-care Therapy Arm for Breast 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 68 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Duration of response (DOR)

Maximum serum concentration of Zanidatamab

Number of Patients reporting Treatment-Emergent Adverse Events (TEAE)

+9 more

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

~1940

Durvalumab

2017

Completed Phase 2

~3870

Gemcitabine

2017

Completed Phase 3

~2070

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor

248 Previous Clinical Trials

33,958 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment phase of this medical study currently ongoing?

"Indeed, as per the details on clinicaltrials.gov, this research trial is actively seeking eligible participants. The study was initially posted on March 1st, 2024 and had its most recent update on February 21st, 2024. A total of 286 individuals are sought from two designated locations."

Answered by AI

What is the current size of the patient cohort being observed in this clinical investigation?

"Affirmative. Documentation on clinicaltrials.gov indicates that this medical investigation is currently seeking eligible participants. The trial was initially posted on March 1st, 2024, and the most recent update occurred on February 21st, 2024. A total of 286 individuals are sought for enrollment at two distinct locations."

Answered by AI

Has the combination of Zanidatamab with standard-of-care therapy arm been granted approval by the FDA?

"Our research team at Power has rated the safety of Zanidatamab in conjunction with Standard-of-care Therapy Arm as a 3 on our scale. This assessment aligns with it being a Phase 3 trial, implying existing efficacy data and robust safety evidence from prior phases."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

2024. "Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06282575.

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