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A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4 in Combination with Azacitidine in Patients with Hematological Malignancies
The purpose of this study is to test the safety of Hu5F9-G4 in participants with blood cancers such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Other purposes of this study are to determine the best dose of Hu5F9-G4, the quantity of Hu5F9-G4 in the participant's blood, the side effects it has on their body, and whether or not it can improve their cancer. Potential participants are being asked to take part in this study because they have been diagnosed with blood cancer and the anti-cancer therapy that they have received so far has not worked.
Primary Objectives: To confirm the safety and tolerability of Hu5F9-G4 monotherapy in this relapsed/refractory AML and MDS population, and of Hu5F9-G4 in combination with azacitidine in previously untreated AML and MDS. To evaluate the efficacy of Hu5F9-G4 monotherapy in relapsed/refractory AML/MDS, and of Hu5F9-G4 in combination with azacitidine in previously untreated AML/MDS, as measured by the objective response rate (ORR). Secondary Objectives: To evaluate the pharmacokinetic (PK) profile of Hu5F9-G4 alone and in combination with azacitidine. To evaluate the immunogenicity of Hu5F9-G4. To evaluate the efficacy of Hu5F9-G4 alone or in combination with azacitidine as measured by the duration of response (DOR), progression-free survival (PFS), relapse-free survival (RFS), and overall survival (OS). Exploratory Objectives: To assess CD47 receptor occupancy. To assess biomarkers of immune cell efficacy and bone marrow penetration of Hu5F9-G4. To assess efficacy in molecular subtypes of AML/MDS.