Clinical Trials

Study closed to enrollment

Key Inclusion Criteria:

• Male or non-pregnant, non-lactating female
• Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
• Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per NCCN criteria)
• Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted
• Measurable disease as defined by RECIST 1.1
• ECOG performance status 0 or 1
• Adequate liver, bone marrow and renal function
• Agree to use contraception per protocol
• Less than Grade 2 pre-existing peripheral neuropathy

Key Exclusion Criteria:

• Prior chemotherapy or radiation for pancreatic cancer
• Solid tumor contact with SMA > 180°
• Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer or in situ carcinoma of the cervix)
• Major surgery within 4 weeks prior to Day 1 study
• History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
• Exposure to another investigational drug within 42 days of first dosing visit, or 5 half-lives of the study product (whichever is longer)
• Uncontrolled intercurrent illness
• Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
• Current abuse of alcohol or drugs