Status:

COMPLETED

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

Lead Sponsor:

Gilead Sciences

Conditions:

Solid Tumor

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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

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...

Eligibility Criteria

Inclusion

  • 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

  • Known primary tumors of central nervous system disease
  • Known active brain metastases
  • Known cardiopulmonary disease

Key Trial Info

Start Date :

August 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2018

Estimated Enrollment :

88 Patients enrolled

Trial Details

Trial ID

NCT02216409

Start Date

August 1 2014

End Date

December 1 2018

Last Update

February 5 2019

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Stanford Cancer Institute

Stanford, California, United States, 94305

2

University of Chicago

Chicago, Illinois, United States, 60637

3

START Midwest

Grand Rapids, Michigan, United States, 49503

4

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10065