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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Gemcitabine; Paclitaxel

Criteria

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