Sponsor: Seattle Genetics, Inc.
Sponsor Study ID: SEA-CD70
Study Title: A Phase 1 Study of SEA CD70 in Myeloid Malignancies
CTO #: 103164
NCT Number: NCT04227847
Phase: I
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Myeloid and Monocytic Leukemia
Study Objectives: This is a phase 1, open-label, multicenter, dose-escalation, and cohort expansion study designed to evaluate the safety, tolerability, PK, and antitumor activity of SEA-CD70 in adults with myeloid malignancies. The study will be conducted in up to 3 parts. Part A is a dose escalation cohort designed to identify the MTD or recommended expansion dose of SEA-CD70 in subjects with relapsed/refractory (HMA-failure) MDS. Part B is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in subjects with relapsed/refractory (HMA-failure) MDS. Part C is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in subjects with relapsed/refractory AML.