Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers

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