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

Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days).
Tumor tissue will be collected during resection for biomarker analysis. EUS core tumor
biopsies will be collected pre/post treatment at participating centers. Tumor response will
be evaluated by changes in CT scan, FDG-PET, CA 19-9, and NCCN® guidelines.

Subjects who complete 6 cycles of treatment will be evaluated for surgical exploration for
possible R0 resection. Subjects who undergo surgery will be evaluated for surgical
complications for an additional 30 days following discharge from surgery. All subjects will
be followed for safety for 28 days following their last dose with study drug. Blood samples
will be collected periodically for the assessment of pharmacokinetics (PK) and
pharmacodynamics (PD).

All subjects, including those who discontinue from the study during the treatment period
without evidence of disease progression, will be followed for at least 28 weeks post End of
Treatment for disease progression, survival, and follow-on treatment for pancreatic cancer.

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