RecruitingPhase 2NCT07192068

Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.

Widening Treatment Options Among Adult Patients With HER2-overexpressing or Mutant Solid Cancers.


Sponsor

UNICANCER

Enrollment

105 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Alterations in the HER2 gene are involved in the development of cancer. These abnormalities are found at highly variable rates (from approximately 2% to 60%) in cancers of the lung, breast, stomach, bile ducts, salivary glands, colon, endometrium, uterus, bladder, bones, blood, etc. Zanidatamab is an anti-cancer drug that acts on cells with alterations in the HER2 gene. It is used in Europe to treat people with bile duct cancer. However, in various clinical trials, zanidatamab has shown promising activity in a few patients with different cancers that have a HER2 gene alteration. This treatment could therefore be effective in several types of cancer once this gene alteration is detected. The primary objective is to evaluate the efficacy of zanidatamab in patients with cancer in one of the following locations: endometrium, colorectal, head and neck, sarcoma or lung cancer. Efficacy will be measured by the number of patients in whom a reduction in tumour size was observed. All patients included in the study will receive zanidatamab by intravenous infusion every 3 weeks. Treatment will continue as long as there is a benefit (stabilisation or regression of the disease). During treatment, participants will visit the hospital regularly for medical consultations to: * assess and treat potential adverse effects of zanidatamab. A dose reduction may be applied to improve tolerance. * monitor disease progression using scans and/or MRI, performed every 6 weeks for the first 18 months of treatment and then every 12 weeks. After treatment is stopped (due to intolerance or disease progression), patients will be monitored according to hospital practices until the end of the trial, i.e. for 1 to 4 years, depending on when they were included in the clinical trial.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called zanidatamab for people with certain cancers that have a specific change in the HER2 gene (overexpression or mutation). It targets cancers of the uterus, colon, head and neck, lung, or soft tissues/bone (sarcoma) that have progressed after standard treatments. **You may be eligible if...** - You are 18 or older - You have confirmed endometrial, colorectal, head and neck, non-small cell lung cancer, or sarcoma that has spread or cannot be surgically removed - Your tumor has been tested and confirmed to have a specific HER2 alteration (overexpression IHC 3+ or, for lung cancer, a HER2 activating mutation) - You have already received and failed at least one standard treatment - Your heart's pumping function is adequate (ejection fraction 50% or above) - Your life expectancy is more than 3 months **You may NOT be eligible if...** - Your cancer has not been confirmed to have the required HER2 change - You have not yet tried available HER2-targeted treatments if one is approved for your cancer type - Your blood counts, liver, or kidney function do not meet required levels - You have significant heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanidatamab

Single arm study where the experimental regimen used for all patients will be zanidatamab, administered intravenously every 3 weeks : * Patients \<70 kg: 1800 mg IV Q3W on Day 1 of each 21-day cycle * Patients ≥70 kg: 2400 mg IV Q3W on Day 1 of each 21-day cycle.


Locations(4)

Institut de Cancérologie de l'Ouest

Angers, France

Chu Timone

Marseille, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT07192068


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