A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
Pancreatic Cancer (Unresectable)
About this trial
This is an interventional treatment trial for Pancreatic Cancer (Unresectable) focused on measuring locally, advanced, pancreatic, cancer, unresectable, pancreatic cancer
Eligibility Criteria
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
Sites / Locations
- HonorHealth Research Institute
- University of California, Los Angeles
- Georgetown University - Medstar Health Research Institute
- Mayo Clinic Florida
- Ochsner Clinic Foundation
- Virginia Piper Cancer Institute
- Thomas Jefferson University
- Virginia Mason Medical Center - Benaroya Research Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
FG-3019 + Gemcitabine + Nab-paclitaxel
Gemcitabine + Nab-paclitaxel
Participants will receive FG-3019 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion on Days 1 and 15 of each treatment cycle and on Day 8 of the first cycle, gemcitabine 1000 mg/square meter (m^2) and nab-paclitaxel 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.
Participants will receive gemcitabine 1000 mg/ meter squared (m^2) and nab-paclitaxel 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.