Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT06581432
Eligibility Criteria:
inclusion criteria:
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
* Patients ≥18 years old or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the Informed consent form (ICF).
* Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:
* HER2 overexpression/amplification
* Known activating HER2 mutations
* Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material
* Patient with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour who has had at least one prior line of therapy for metastatic disease. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.
Further inclusion criteria apply.
exclusion criteria:
* Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC) (except where there is co-existing presence of HER2 overexpression / amplification)
* Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 years except:
* effectively treated non-melanoma skin cancers
* effectively treated carcinoma in situ of the cervix
* effectively treated ductal carcinoma in situ of the breast
* localised prostate cancer on watchful waiting or active surveillance
* other effectively treated malignancy that is considered cured by local treatment.
* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
* Not completely recovered from major surgery (major according to the investigator's assessment) performed prior to screening or planned within 6 months after screening, e.g. hip replacement Further exclusion criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06581432
Study Brief:
Protocol Section:
NCT06581432