Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers

Last updated: January 5, 2022
Sponsor: Five Prime Therapeutics, Inc.
Overall Status: Completed

Phase

1

Condition

Pancreatic Cancer

Gliomas

Head And Neck Cancer

Treatment

N/A

Clinical Study ID

NCT02526017
FPA008-003
  • Ages > 18
  • All Genders

Study Summary

Phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in SolidTumors (RECIST) v1.1 criteria.
  • Patients must have had progressive disease on, after, or refused, appropriate approvedtherapy for their tumor type.
  • Patients must have histologically or cytologically confirmed solid tumor that islocally recurrent or metastatic and has progressed following standard treatment or isnot appropriate for standard treatment
  • Understand and sign an Institutional review board/Independent ethics committee (IRB/IEC)-approved informed consent form (ICF) prior to any study-specific evaluation
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Willing and able to comply with all study procedures

Exclusion

Exclusion Criteria:

  • Current or history of clinically significant muscle disorders (e.g., myositis), recentunresolved muscle injury, or any condition known to elevate serum creatine kinase (CK)levels
  • Decreased cardiac function with New York Heart Association (NYHA) > Class 2
  • Uncontrolled or significant heart disorder such as unstable angina
  • Significant abnormalities on electrocardiogram (ECG) at screening. Fridericia'scorrection formula for QT interval (QTcF) > 450 msec for males or > 470 msec forfemales at screening
  • History of anti-drug antibodies, severe allergic, anaphylactic, or otherinfusion-related reaction to a previous biologic agent
  • Positive test for latent tuberculosis (TB) at screening (Quantiferon test) or evidenceof active TB
  • Patients with abnormal serum chemistry values, which in the opinion of theInvestigator is considered to be clinically significant, will be excluded from thestudy
  • Lack of peripheral venous or central venous access or any condition that wouldinterfere with drug administration or collection of study samples
  • Any uncontrolled medical condition or psychiatric disorder which, in the opinion ofthe Investigator, would pose a risk to patient safety or interfere with studyparticipation or interpretation of individual patient results
  • Pregnant or breastfeeding
  • Current unresolved infection or history of chronic, active, clinically significantinfection (viral, bacterial, fungal, or other) which, in the opinion of theInvestigator, would preclude the patient from exposure to a biologic agent or pose arisk to patient safety
  • Prior exposure to any colony stimulating factor 1 receptor (CSF1R) pathway inhibitors

Study Design

Total Participants: 313
Study Start date:
September 08, 2015
Estimated Completion Date:
November 18, 2019

Study Description

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

Connect with a study center

  • Scottsdale Healthcare Hospitals DBA Honor Health

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Moores UC San Diego Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Norris Comprehensive Cancer Center, University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • UC Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Sarcoma Oncology Research Center

    Santa Monica, California 90403
    United States

    Site Not Available

  • UCLA Hematology/Oncology- Santa Monica

    Santa Monica, California 90404
    United States

    Site Not Available

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Indiana University Health Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Norton Cancer Institute, Norton Healthcare Pavilion

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Allina Health, Virginia Piper Cancer Institute

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Winthrop University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • Memorial Sloan Kettering

    New York, New York 10065
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pittsburgh Cancer Institute, William M. Cooper Ambulatory Pavilion of the Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Hollings Cancer Center, Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Henry-Joyce Cancer Clinic, Vanderbilt-Ingram Cancer Center,

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Baylor Charles A. Sammons Cancer Center, Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Mischer Neuroscience Associates, The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Cancer Therapy & Research Center, University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Site Not Available

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