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

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

Completed

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford Cancer Institute, Stanford, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hu5F9-G4

Drug

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Aug 15, 2014
Registry last updated: Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed