The study involves a Phase 1b dose escalation portion with up to 30 patients to determine the MTD using a 3+3 dose escalation design and to designate a dose level for the Phase 2 expansion phase (RP2D).~The Phase 2 portion of the study will consist of an expansion cohort of up to 39 patients receiving HCW9218 monotherapy at the RP2D level. An additional independent Phase 2 cohort of patients receiving HCW9218 at the RP2D level in sequence with gemcitabine and nab-paclitaxel will also be considered.
This is a Phase 1b/2, open-label, multi-center, competitive enrollment and dose-escalation study of HCW9218 in patients with advanced/metastatic pancreatic cancer.