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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and clinical benefit of FPA008 in combination with nivolumab in patients with selected advanced cancers.

Official Title

A Phase 1a/1b Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers

Keywords

Advanced Solid Tumors, Including But Not Limited to Lung Cancer Head and Neck Cancer Pancreatic Cancer Ovarian Cancer Renal Cell Carcinoma Malignant Glioma Nivolumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients must have at least one measurable lesion at baseline by computed tomography(CT) or magnetic resonance imaging (MRI) as per RECIST v1.1 criteria.
  • Patients must have had progressive disease on, after, or refused, appropriate approved therapy for their tumor type.
  • Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation
  • ECOG performance status of 0 or 1
  • Willing and able to comply with all study procedures

You CAN'T join if...

  • Current or history of clinically significant muscle disorders (e.g., myositis),recent unresolved muscle injury, or any condition known to elevate serum CK levels
  • Decreased cardiac function with NYHA> Class 2
  • Uncontrolled or significant heart disorder such as unstable angina
  • Significant abnormalities on ECG at screening. QTcF>450 msec for males or>470 msec for females at screening
  • History of anti-drug antibodies, severe allergic, anaphylactic, or other infusion-related reaction to a previous biologic agent
  • Positive test for latent tuberculosis (TB) at screening (Quantiferon test) or evidence of active TB
  • Patients with abnormal serum chemistry values, which in the opinion of the Investigator is considered to be clinically significant, will be excluded from the study
  • Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
  • Any uncontrolled medical condition or psychiatric disorder which, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study participation or interpretation of individual patient results
  • Pregnant or breastfeeding
  • Current unresolved infection or history of chronic, active, clinically significant infection (viral, bacterial, fungal, or other) which, in the opinion of the Investigator, would preclude the patient from exposure to a biologic agent or pose a risk to patient safety
  • Prior exposure to any CSF1R pathway inhibitors

Locations

  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento, California, 95817, USA
  • Moores UC San Diego Cancer Center accepting new patients
    La Jolla, California, 92093, USA
  • Norris Comprehensive Cancer Center, University of Southern California accepting new patients
    Los Angeles, California, 90033, USA
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Center accepting new patients
    Los Angeles, California, 90048, USA
  • Sarcoma Oncology Research Center accepting new patients
    Santa Monica, California, 90403, USA
  • UCLA Hematology/Oncology- Santa Monica accepting new patients
    Santa Monica, California, 90404, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Five Prime Therapeutics, Inc.
ID
NCT02526017
Phase
Phase 1
Lead Scientist
Nicholas Butowski
Study Type
Interventional
Last Updated
March 2017
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