A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer

A Randomized, Open Label, Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer

This is a Phase 1/2 trial to evaluate the safety, tolerability, and efficacy of FG-3019 administered with gemcitabine and nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.

Key Inclusion Criteria:

• Male, or non-pregnant and, non-lactating female
• Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
• Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per National Comprehensive Cancer Network® [NCCN®] criteria)
• Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted.
• Measurable disease as defined by RECIST 1.1
• Eastern Cooperative Oncology Group (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 superior mesenteric artery (SMA) >180°
• Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer and in situ carcinomas)
• Major surgery, within 4 weeks prior to Day 1 on 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 participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
• Current abuse of alcohol or drugs