Sponsor: HCW Biologics, Inc
Sponsor Study ID: HCWPAN102
Study Title: A Phase 1b/2 Study of HCW9218, a Bifunctional TGF ß Antagonist/IL 15 Protein Complex, for Advanced Pancreatic Cancer
CTO #: 103518
NCT Number: NCT05304936
Phase: I/II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Pancreas
Study Objectives: Evaluate the safety profile (as outlined by incidence of adverse events (AEs) based on CTCAE v5) of HCW9218 monotherapy in subjects with advanced/metastatic pancreatic cancer who have progressed on or are intolerant of standard first-line therapy. Determine the maximum tolerated dose (MTD) and designate the recommended Phase 2 dose level (RP2D) for Phase 2 study of HCW9218 in HCW9218-treated subjects. Evaluate the safety profile of HCW9218 in treated subjects. Determine the 6-month progression-free survival (PFS) rate of evaluable subjects treated with HCW9218.