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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02216409
Recruitment Status : Recruiting
First Posted : August 15, 2014
Last Update Posted : July 18, 2017
Information provided by (Responsible Party):
Forty Seven, Inc.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
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
Study Start Date : August 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: Treatment (Hu5F9-G4) Drug: Hu5F9-G4

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.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT02216409

Contact: Chris Takimoto, MD

United States, California
Stanford Cancer Institute Recruiting
Stanford, California, United States, 94305
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49503
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Forty Seven, Inc.
Study Chair: Chris Takimoto, MD Forty Seven, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Forty Seven, Inc. Identifier: NCT02216409     History of Changes
Other Study ID Numbers: VAR0113
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017