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