HCW9218 for Advanced Solid Cancers

Overseen By Cancer Center Info Nurse

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Masonic Cancer Center, University of Minnesota

Must not be taking: St. John's wort

Disqualifiers: Pregnancy, Vascular disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

18 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use St. John's wort or other herbal CYP modulators starting 7 days before the trial and during the study. Also, if you have an autoimmune disease requiring treatment with certain medications, you may not be eligible.

Research Team

Melissa Geller, MD

Principal Investigator

Masonic Cancer Center, Univeristy of Minnesota

Eligibility Criteria

Adults with advanced solid tumors (excluding pancreatic and primary brain cancers) who have tried at least two treatments without success. They must be in fairly good health, not planning to get pregnant, and agree to use contraception. People can't join if they've had certain heart issues, untreated brain metastases, recent cancer treatment or other specific medical conditions.

Inclusion Criteria

My lung function is more than half of what is expected.

My cancer has spread, isn't pancreatic/brain cancer, and 2 treatments have failed.

Provides voluntary written consent prior to the performance of any research related activity

Exclusion Criteria

Other illness or medical issues that would exclude the subject from participating in this study

I am currently being treated for an autoimmune disease.

I am currently on IV antibiotics for an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks

12 months

Injections every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• HCW9218

Trial Overview The trial is testing HCW9218, a new bi-functional fusion protein complex for treating advanced solid tumors. It's given as an injection under the skin and works by activating immune cells while trapping harmful proteins that can affect tumor growth.

Participant Groups

Group I: Administer HCW9218 Experimental Treatment 1 Intervention

Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level -1 - 0.1 mg/kg 1. - (start) 0.25 mg/kg 2. - 0.5 mg/kg 3. - 0.8 mg/kg 4. - 1.2 mg/kg

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+