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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02216409
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Hu5F9-G4 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies
Actual Study Start Date : August 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : December 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (Hu5F9-G4)
Hu5F9-G4 monotherapy
 Drug: Hu5F9-G4


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216409


Locations
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United States, California
Stanford Cancer Institute
Stanford, California, United States, 94305
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Michigan
START Midwest
Grand Rapids, Michigan, United States, 49503
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Chair: Chris Takimoto, MD Gilead Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02216409    
Other Study ID Numbers: SCI-CD47-001
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Magrolimab
Antineoplastic Agents, Immunological
Antineoplastic Agents