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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT02216409

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

14.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

N/A

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 :

Aug 1, 2014

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment (Hu5F9-G4)

Hu5F9-G4 monotherapy

Drug: Hu5F9-G4

Outcome Measures

Primary Outcome Measures

Safety and Tolerability of Hu5F9-G4 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
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
5	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
6	South Texas Accelerated Research Therapeutics	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Chair: Chris Takimoto, MD, Gilead Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT02216409

Other Study ID Numbers:

SCI-CD47-001

First Posted:

Aug 15, 2014

Last Update Posted:

Feb 5, 2019

Last Verified:

Feb 1, 2019

Additional relevant MeSH terms:

Magrolimab

Study Results

No Results Posted as of Feb 5, 2019