Phase 1 Trial of Hu5F9-G4, a CD47-targeting Antibody

February 1, 2019 updated by: Gilead Sciences

A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies

The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a first-in-human, first-in-class, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • START Midwest
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with histologically or cytologically confirmed advanced solid malignancy or Lymphoma

Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatment.

Adequate hematologic status

Adequate coagulation function

Adequate hepatic function

Adequate renal function

Exclusion Criteria:

Known primary tumors of central nervous system disease

Known active brain metastases

Known cardiopulmonary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (Hu5F9-G4)
Hu5F9-G4 monotherapy
Drug: Hu5F9-G4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Hu5F9-G4
Time Frame: The first 28 days on study, for determination of Dose Limiting Toxicities
The CTCAE criteria will be used to assess adverse events on this trial.
The first 28 days on study, for determination of Dose Limiting Toxicities

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Chair: Chris Takimoto, MD, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-CD47-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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