HCW9218 for Advanced Solid Cancers

CC
Overseen ByCancer Center Info Nurse
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Masonic Cancer Center, University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called HCW9218 for individuals with advanced solid cancers, excluding pancreatic and primary brain cancers. The study aims to determine the optimal dose of HCW9218, which boosts the immune system and blocks proteins that promote tumor growth. This trial may suit those who have tried at least two treatments without success and still have measurable symptoms. Participants will receive the treatment through a simple injection every three weeks. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that HCW9218 is likely to be safe for humans?

Research has shown that HCW9218, a new treatment for advanced solid tumors, generally has a manageable safety profile in early studies. While side effects may occur, most patients can tolerate them. The main goal of these studies was to determine the highest dose patients can take without serious issues. So far, HCW9218 has not shown any unexpected or major safety problems. However, as testing continues, ongoing research will closely monitor its safety.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced solid cancers, which often involve chemotherapy, radiation, or surgery, HCW9218 is a unique option because it is a biologic agent administered as a subcutaneous injection. HCW9218 works by harnessing the immune system to fight cancer cells, potentially offering a more targeted approach with fewer side effects. Researchers are particularly excited about its novel mechanism of action, which involves modulating immune responses to enhance the body’s natural ability to combat cancer. This could pave the way for a new generation of cancer therapies that are more effective and less taxing on patients.

What evidence suggests that HCW9218 might be an effective treatment for advanced solid cancers?

Research has shown that HCW9218 might help treat advanced solid tumors. Early results suggest that HCW9218 strengthens the body's immune system to fight cancer. It activates certain immune cells and blocks TGF-β, a protein that can promote cancer growth. Studies have found that HCW9218 improves the effectiveness of chemotherapy in fighting tumors. So far, patients have tolerated the treatment well, even at higher doses.12467

Who Is on the Research Team?

MG

Melissa Geller, MD

Principal Investigator

Masonic Cancer Center, Univeristy of Minnesota

Are You a Good Fit for This Trial?

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
See 5 more

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.
See 12 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Administer HCW9218Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials
285
Recruited
15,700+

Citations

HCW9218 in Select Advanced Solid TumorsThis is a single center, Phase I dose finding study of HCW9218 for the treatment of advanced/metastatic solid tumor cancer (except ...
724 A phase I study of HCW9218, a bifunctional TGF-β ...The primary objective of this Phase I first-in-human clinical trial is to determine the maximum tolerated dose of HCW9218 in advanced solid tumors.
Pre-clinical and First-in-Human Studies of HCW9218, a ...Repeated HCW9218 administration at up to 1.2 mg/kg was well tolerated by heavily pretreated advanced solid tumor patients. • HCW9218 treatment resulted in NK ...
Immunotherapeutic HCW9218 augments anti-tumor activity ...Together, these data show that HCW9218 enhanced the efficacy of chemotherapies against multiple types of solid tumors by augmenting immune responses in the ...
HCW9218 for Advanced Solid Cancers · Info for ParticipantsThis is a single center, Phase I dose finding study of HCW9218 for the treatment of advanced/metastatic solid tumor cancer (except pancreatic and primary ...
NCT05304936 | HCW9218 for Advanced Pancreatic CancerThe 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 ...
EV260/#767 Phase I study of HCW9218, a bifunctional TGFWe report a first-in-human, phase I study of HCW9218 monotherapy in patients with advanced solid tumors. ... HCW9218 has a manageable safety profile ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security