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

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ClinicalTrials.gov Identifier: NCT02216409
Recruitment Status : Active, not recruiting
First Posted : August 15, 2014
Last Update Posted : June 1, 2018
Sponsor:
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)
Actual Enrollment : 88 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
Actual Study Start Date : August 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

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



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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


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
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
Forty Seven, Inc.
Investigators
Study Chair: Chris Takimoto, MD Forty Seven, Inc.