(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer

Inclusion Criteria

• •1. Male or female ≥ 18 years
• •2. Histologically or cytologically confirmed adenocarcinoma of the pancreas, including pancreatic adenosquamous carcinoma, pancreatic anaplastic adenocarcinoma, pancreatic signet ring carcinoma, papillary mucinous carcinoma, acinar cell carcinoma, and ampulla of vater carcinoma,that is locally advanced (not able to proceed with surgery), recurrent, or metastatic (mixed adenocarcinoma of the pancreas is acceptable where the invasive component is predominantly adenocarcinoma)
• •3. Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1
• •4. Has an ECOG PS of 0, 1, or 2
• •5. Has been off chemotherapy for \> or = 2 weeks
• •6. Has a patent biliary stent if required for biliary ductal obstruction, has adequate nutritional intake, and pain which is stable for a minimum of 24 hrs (pain score ≤ 3/10)
• •7. Has total bilirubin \< 2 mg/dL, AST and ALT \< 3.0 × ULN or \< 5 x ULN for subjects with known hepatic metastases
• •8. Has serum creatinine \< 2.5 × ULN
• •9. Has hemoglobin ≥ 9 g/dL, ANC ≥ 1.0 × 10\^9/L, and platelet count ≥ 100 × 10\^9/L
• •10. Must be willing and able to comply with study
• •11. Has read, understood and signed the ICF
• •12. Women of childbearing potential must not be pregnant or breast-feeding. In addition, a medically acceptable method of birth control must be used or total abstinence. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.
• •13. Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms at least 30 days after the last dose of study drug. Total abstinence is an acceptable alternative.
• •14. Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.
• •15. Availability of tissue if applicable (from the primary tumor or metastases)for banking
• •16. Willingness to donate blood for biomarker studies
• •17. Must have received at least one prior systemic chemotherapy on which disease progressed