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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT04650451
Eligibility Criteria:
Inclusion Criteria:
* Documented evidence of HER2 amplification/overexpression by local testing.
* Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic HER2+ solid tumor malignancy for which standard treatment is no longer effective, does not exist, or subject is ineligible.
* Subjects with a solid tumor malignancy for which HER2-targeted therapy is approved as a standard treatment (e.g., breast, gastric cancers) must have received prior treatment with approved HER2-directed therapy.
* Measurable disease (at least one target lesion) per RECIST v1.1.
* Life expectancy \> 12 weeks.
* ECOG 0-1.
* Adequate organ function.
Exclusion Criteria:
* Symptomatic, untreated, or actively progressing central nervous system metastases.
* Prior CAR T cell or other genetically-modified T cell therapy.
* Impaired cardiac function or clinically significant cardiac disease.
* Symptomatic intrinsic lung disease or those with extensive tumor involvement of the lungs.
* Severe intercurrent infection.
* Pregnant or breastfeeding.
* Known HIV positivity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04650451
Study Brief:
Protocol Section:
NCT04650451