Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kyntra Bio
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
