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

  • Interventional
  • Not Recruiting
  • NCT02216409
Eligibility Details Visit Clinicaltrials.gov

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

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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
  • Solid Tumors

At a Glance

National Government IDNCT02216409

IRB#IRB17-1217

Lead SponsorForty Seven, Inc.

Lead PhysicianGini Fleming

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting