Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER
About this trial
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 criteria
Qualifiers
Histologically or cytologically confirmed endometrial, colorectal, head & neck, non-small cell lung cancer (NSCLC), or sarcoma
Patient with progressive, unresectable and/or advanced or metastatic disease harboring a locally performed, centrally reviewed HER2-overexpressing (IHC 3+ exclusively) for endometrial, colorectal, head & neck cancers, or sarcoma or a HER2 activating mutation for NSCLC, determined on tissue (see Section 7.1.2 of the protocol)
Age ≥ 18 years at inclusion
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Disqualifiers
Patient, in the judgment of the investigator, who should be included in another recruiting study assessing an anti-HER2 therapy (including zanidatamab)
Patient who received prior treatment with HER2-directed therapy unless marketed for the study cohort indication.
Other primary malignancies within 3 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivor, who has undergone potentially curative therapy for a prior malignancy, has no evidence of that disease for 4 years or more and is deemed at negligible risk for recurrence, is eligible for the trial
Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement not related to lung metastases (e.g. rheumatoid arthritis, Sjögren's syndrome, sarcoidosis)
Trial design
Treatments tested in this trial
- Zanidatamab
Treatment groups
105 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov