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