This is a single center, Phase I dose finding study of HCW9218 for the treatment of advanced/metastatic solid tumor cancer (except pancreatic and primary brain cancers). HCW9218 is a novel bi-functional fusion protein complex administered by subcutaneous (SC) injection. It is comprised of a soluble fusion of two human TGFβRII domains, human tissue factor, and human IL-15, and a second soluble fusion of two human TGFβRII domains and a sushi domain of human IL-15Rα. HCW9218 activates IL-15R signaling on effector immune cells and the dimeric TGFβRII functions as a "trap" for all three human TGF-β isoforms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
Masonic Cancer Center - University of Minnesota
Minneapolis, Minnesota, United States
The Primary Objective of the Dose Finding Component is to Determine the Maximum Tolerated Dose (MTD) of HCW9218
Given that little to no toxicity is expected, the MTD will be determined using an adaptation of the continual reassessment method (CRM) (O'Quigley, 1996) starting with 1 patient cohorts.
Time frame: through study completion, an average of 12 months
Estimate Response Rate (Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Response rate will be estimated by a simple proportion with 95% confidence limits if sufficient numbers exist
Time frame: 3 months after 1st dose
Estimate Response Rate (Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Response rate will be estimated by a simple proportion with 95% confidence limits if sufficient numbers exist
Time frame: 6 months after 1st dose
Estimate Response Rate (Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Response rate will be estimated by a simple proportion with 95% confidence limits if sufficient numbers exist
Time frame: 12 months after 1st dose
Estimate Progression of Overall Survival (OS)
Estimated with Kaplan-Meier curves
Time frame: 6 months after 1st dose
Estimate Progression Free Survival (PFS)
Estimated with Kaplan-Meier curves
Time frame: 6 months after 1st dose
Estimate Progression Free Survival (PFS)
Estimated with Kaplan-Meier curves
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 year after 1st dose
Estimate Progression of Overall Survival (OS)
Estimated with Kaplan-Meier curves
Time frame: 1 year after 1st dose