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

Gilead Sciences6 sites in 1 country88 target enrollmentAugust 2014

ConditionsSolid Tumor

InterventionsHu5F9-G4

DrugsHu5F9-G4

Overview

Phase: Phase 1
Intervention: Hu5F9-G4
Conditions: Solid Tumor
Sponsor: Gilead Sciences
Enrollment: 88
Locations: 6
Primary Endpoint: Safety and Tolerability of Hu5F9-G4
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

December 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility 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