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

Trial ID #	NCT02216409
Phase	I
Drug Class	Immunotherapy: Checkpoint Inhibitors/CD47
Drug Name	Magrolimab
Alternate Drug Names	Hu5F9-G4, anti-CD47 monoclonal antibody Hu5F9-G4
Drugs in Trial	Magrolimab
Eligible Participant	Advanced solid tumors
Patients Enrolled	62 (13 ovarian)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, RP2D, evaluated per RECIST
Efficacy	RP2D: 1 mg/kg priming dose on Day 1 followed my maintenance dose of 30 mg/kg weekly ORR: 15.4% (2PR, n=13) Two OvCa patients with > 6 prior therapies, at 20 mg/kg maintenance dose: One CC OvCa with TTP 5.2 months, 50% reduction in tumor lesion, CA125 drop from 338 to 70 U/ml One FT OvCa with TTP 9.2 months, 44% reduction in tumor lesion, CA125 drop from 890 to 103 U/ml
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: decreased lymphocyte counts (18.2%), anemia (13.6%)
Conclusion	Promising activity with manageable toxicity in CC and FT OvCa
Reference	Sikic BI et al. First-in-Human, First-in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With Advanced Cancers. J Clin Oncol (2019) 37(12):946-953 https://www.ncbi.nlm.nih.gov/pubmed/30811285