Spots Global Cancer Trial Database for HCW9218 for Advanced Pancreatic Cancer
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Trial Identification
Brief Title: HCW9218 for Advanced Pancreatic Cancer
Official Title: A Phase 1b/2 Study of HCW9218, a Bifunctional TGF-β Antagonist/IL-15 Protein Complex, for Advanced Pancreatic Cancer
Study ID: NCT05304936
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth, Scottsdale, Arizona, United States
National Institute of Health/ National Cancer Institute, Bethesda, Maryland, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
Cleveland Clinic, Cleveland, Ohio, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Contact Details
Name: Pallavi Chaturvedi
Affiliation: HCW Biologics
Role: STUDY_DIRECTOR
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