Overview

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