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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: Hu5F9-G4

• Registration Number: NCT02216409
• Lead Sponsor: Gilead Sciences

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 of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-15
• Primary Completion: 2018-10
• Study Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

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Exclusion Criteria

Known primary tumors of central nervous system disease

Known active brain metastases

Known cardiopulmonary disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (Hu5F9-G4)	Hu5F9-G4	Hu5F9-G4 monotherapy

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Stanford Cancer Institute; 🇺🇸 Stanford, California, United States

START Midwest; 🇺🇸 Grand Rapids, Michigan, United States