HER3 DNA
Vaccine Phase I Trial Eligibility Criteria

Inclusion Criteria:

• 18 years or older

• ECOG PS 0-1

• Documented diagnosis of solid tumor where HER3 expression is expected (this includes breast, colon, lung, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, liver, and esophageal cancer, but other tumors will be considered based on emerging HER3 expression data in the literature). Demonstration of HER3 expression is not required for enrollment.

• Has undergone surgical resection of the solid tumor and has completed intended standard course of chemotherapy, HER2 targeted therapy (if indicated) and radiotherapy (if indicated) under the direction of their physician. Subjects may continue on adjuvant hormonal therapy (for example, aromatase inhibitors as adjuvant therapy for ER/PR+ breast cancer.)

• At least 3 weeks and up to 2 years since completing prior chemotherapy, HER2-targeted therapy, or radiation therapy. 

• Has no evidence of disease by standard imaging studies (performed at the direction of their physician) within 30 days prior to initiating study treatment.

Adequate laboratory values for hematologic, renal, and hepatic function.     

• Must not have a history of autoimmune disease requiring immunosuppressive therapy, serious intercurrent chronic or acute illness, active hepatitis, or known HIV. 

• Pregnant women and nursing mothers are excluded.