Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05304936 | HCW9218 for Advanced Pancreatic Cancer | PHASE1 | COMPLETED | 21 | — | — | Oct 17, 2022 | Feb 15, 2025 | Apr 15, 2026 | 5 | United States |
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
| Arm | Type | Description |
|---|---|---|
| HCW9218 | EXPERIMENTAL | Experimental Arm: HCW9218 |
| Name | Type | Description |
|---|---|---|
| HCW9218 | DRUG | Bifunctional TGF-β (Transforming Growth Factor Beta) antagonist/IL-15 (Interleukin-15) protein complex |
| Gemcitabine (GEM) | DRUG | Gemcitabine is administered as a combination chemotherapy regimen for the treatment of advanced/metastatic pancreatic cancer in accordance with standard-of-care dosing and schedule per protocol |
| Nab-paclitaxel | DRUG | Nab-paclitaxel is administered as a combination chemotherapy regimen for the treatment of advanced/metastatic pancreatic cancer in accordance with standard-of-care dosing and schedule per protocol |
Inclusion Criteria Subjects must meet all of the following criteria for inclusion in the study (to be verified by Sponsor prior to subject enrollment): 1. Histologically or cytologically confirmed unresectable, advanced/metastatic disease pancreatic cancer that has progressed on standard first-lin...