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:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT03680560
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent obtained prior to study procedures
* Histologically-confirmed Her2 positive advanced solid tumor malignancy with documented disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer
* Subjects must have previously received adequate standard therapy for treatment of their malignancy
* For those with metastatic breast cancer, must have received HER2-directed therapy including trastuzumab, pertuzumab and ado-trastuzumab in any breast cancer disease setting
* For those with advanced gastric cancer, adequate prior treatment with HER2-directed chemotherapy is required
* At least 1 measurable lesion by iRECIST
* Able to provide fresh tumor biopsy or archived block specimen taken since time of most recent anti-HER2 mAb-directed therapy
* ECOG of 0 or 1
* Life expectancy ≥ 6 months
* LVEF ≥ 50% by MUGA or ECHO
* Absolute neutrophil (ANC) count ≥ 1500/ µL
* Platelet count ≥ 100,000/µL
* Hemoglobin ≥ 9g/dL
* Estimated GFR \>30mL/min/1.73m2
Exclusion Criteria:
* glioblastoma multiforme or other primary CNS tumors are excluded
* clinically significant cardiac disease
* clinically significant active infection
* clinical history, prior diagnosis, or overt evidence of autoimmune disease
* current use of more than 5mg/day of prednisone (or an equivalent glucocorticoid)
* Prior treatment as follows:
* prior cumulative doxorubicin dose greater than or equal to 300 mg/m\^2 or equivalent
* chemotherapy within 2 weeks of enrollment
* external beam radiation within 2 weeks of enrollment (28 days if CNS-directed therapy)
* any monoclonal antibody (mAb) or other protein therapeutic containing Fc-domains within 4 weeks of enrollment
* pertuzumab within 4 months of enrollment
* Experimental agents within 3 half-lives or 28 days prior to enrollment, whichever is shorter
* allogeneic hematopoietic stem cell transplant (HSCT)
* prior infusion of a genetically modified therapy
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03680560
Study Brief:
Protocol Section:
NCT03680560