Actively Recruiting
Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.
Led by UNICANCER · Updated on 2025-12-19
105
Participants Needed
4
Research Sites
242 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with endometrial, colorectal, head and neck, non-small cell lung cancer, or sarcoma confirmed by tissue analysis
- Cancer is progressive, advanced, metastatic, or unresectable and has a HER2 overexpression (IHC 3+) or HER2 activating mutation
- Age 18 years or older at the time of inclusion
- ECOG performance status of 0, 1, or 2
- Disease progressed after at least one prior therapy with no other standard treatment options available
- Patients with prior HER2-targeted therapy included only if standard anti-HER2 treatments have been exhausted
- Estimated life expectancy greater than 3 months
- Measurable disease according to RECIST1.1 criteria
- Adequate bone marrow function (ANC ≥1.5 x 10⁹/L, platelets ≥75 x 10⁹/L, hemoglobin ≥9 g/dL)
- Adequate liver function with bilirubin ≤1.5 times upper normal limit (or ≤3.0 with Gilbert syndrome or liver metastasis) and AST/ALT ≤2.5 times upper normal limit (or ≤5 with tumor liver involvement)
- Adequate cardiac function with left ventricular ejection fraction ≥50%
- Normal prothrombin time and partial thromboplastin time unless on anticoagulants
- Adequate kidney function with estimated creatinine clearance ≥30 mL/min
- Men and women of childbearing potential agree to use highly effective contraception during and after the study
- Women of childbearing potential have a negative pregnancy test before treatment
- Availability of suitable archived tumor tissue sample or consent to optional biopsy
- Willing and able to comply with study procedures and visits
- Affiliated with a social security system
- Signed informed consent form prior to trial procedures
You will not qualify if you...
- Currently participating in another study assessing anti-HER2 therapy
- Prior HER2-directed therapy not approved for the study indication
- Other primary cancers within past 3 years except treated cervical in situ carcinoma or skin cancers
- Autoimmune or inflammatory lung diseases unrelated to cancer metastases
- Prior removal of a lung (pneumonectomy)
- Severe or uncontrolled systemic diseases that affect study compliance
- Recent serious heart conditions including myocardial infarction or unstable angina within 6 months
- Active or symptomatic brain metastases requiring treatment
- Evidence of leptomeningeal disease or neurologic symptoms from it
- Uncontrolled pancreatitis or severe liver disease (Child-Pugh Class C)
- Unresolved toxicities from previous cancer treatments above grade 1 except alopecia
- Use of systemic corticosteroids above 10 mg prednisone equivalent within 2 weeks before treatment unless approved
- Recent anthracycline treatment within 90 days or exceeding lifetime dose limits
- History of life-threatening allergic reactions to monoclonal antibodies
- Pregnant or breastfeeding women
- Participation in another therapeutic clinical trial within 30 days prior
- Unable or unwilling to comply with follow-up due to social or psychological reasons
- Individuals under legal custody or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Institut de Cancérologie de l'Ouest
Angers, France
Active, Not Recruiting
2
Chu Timone
Marseille, France
Actively Recruiting
3
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Active, Not Recruiting
4
Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
C
Céline MAHIER AIT OUKHATAR
CONTACT
M
Marta JIMENEZ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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