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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:August 2014
End Date:December 2018

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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.

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.

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
We found this trial at
6
sites
Grand Rapids, Michigan 49503
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Grand Rapids, MI
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Oklahoma City, OK
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San Antonio, TX
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Stanford, California 94305
Principal Investigator: Branimir I. Sikic, M.D.
Phone: 650-498-4331
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Stanford, CA
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