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

FGCL-3019-069

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.

2014-07-31

2021-12-15

2021-12-15

Completed

Early phase I

37

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}

2023-03-02