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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Hu5F9-G4

Study type: Interventional

Funder types: Industry

Identifiers

NCT02216409

SCI-CD47-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Treatment (Hu5F9-G4)

Experimental group

Description:

Hu5F9-G4 monotherapy

Treatment:

Drug: Hu5F9-G4