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

This study is currently recruiting participants.
Verified July 2017 by Forty Seven, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02216409
First Posted: August 15, 2014
Last Update Posted: July 18, 2017
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.
Information provided by (Responsible Party):
Forty Seven, Inc.
  Purpose
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.

Condition Intervention Phase
Solid Tumor Drug: Hu5F9-G4 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Forty Seven, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 96
Study Start Date: August 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (Hu5F9-G4) Drug: Hu5F9-G4

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


Contacts
Contact: Chris Takimoto, MD info@fortyseveninc.com

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forty Seven, Inc.
ClinicalTrials.gov Identifier: NCT02216409     History of Changes
Other Study ID Numbers: VAR0113
First Submitted: August 12, 2014
First Posted: August 15, 2014
Last Update Posted: July 18, 2017
Last Verified: July 2017