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Solid TumorPhase 1NCT05322408

HCW9218 in Select Advanced Solid Tumors

A Phase 1 study testing HCW9218 in people with Solid Tumor, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
HCW9218
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
1 Apr 2022to 28 Feb 2025
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed advanced/metastatic solid tumor cancer (except pancreatic and primary brain cancers), has failed at least 2 prior lines of therapy given either in the recurrent or metastatic setting and must be refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
  • Measurable disease per RECIST v 1.1.
  • Acute effects of any prior therapy must have resolved to baseline or Grade ≤1 NCI CTCAE v5 except for AEs not constituting a safety risk by enrolling Investigator judgment.
  • Age 18 years or older at the time of consent.
  • ECOG Performance Status 0 or 1.
  • Evidence of adequate organ function within 14 days prior to enrollment as defined in Section 4.1.6.
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  • Adequate pulmonary function with PFTs >50% FEV1 if symptomatic or known impairment.
  • Sexually active persons of child-bearing potential or with partners of childbearing potential must agree to use a highly effective form of contraception (refer to Section 4.1.10 for acceptable methods) for at least 28 days after the last dose of HCW9218.
  • Provides voluntary written consent prior to the performance of any research related activity.

Who cannot join

  • Pregnant or breastfeeding.
  • History of clinically significant vascular disease, including any of the following within 6 months prior to start of study treatment: MI or unstable angina, percutaneous coronary intervention, bypass grafting, ventricular arrhythmia requiring medication, stroke or transient ischemic attack, symptomatic peripheral arterial disease.
  • Marked baseline prolongation of QT/QTc interval (e.g., demonstration of a QTc interval greater or equal to 470 milliseconds by Fridericia's correction).
  • Known or suspected untreated CNS metastases.
  • Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days before treatment start.
  • Other prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the subject is currently in complete remission, or any other cancer from which the subject has been disease-free for 3 years after surgical treatment.
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  • Known hypersensitivity or history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study.
  • Prior therapy with TGF-β antagonist, IL-15 or analogs.
  • Concurrent use of St. John's wort and and/or other herbal CYP modulators within 7 days of Day 1. Must agree to not use during study treatment through the end of treatment visit to be eligible.
  • Known autoimmune disease requiring active treatment. Persons with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
  • Prior organ allograft or allogeneic transplantation.
  • Known HIV-positive or AIDS.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Other illness or a medical issue that in the opinion of the Investigator would exclude the subject from participating in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Masonic Cancer Center - University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: A Phase I Study of HCW9218, a Bifunctional TGF-B; Antagonist/IL-15 Protein Complex, in Select Advanced Solid Tumors After Failing at Least Two Prior Therapies

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.

Conditions
Solid Tumor
Being tested
HCW9218

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HCW9218Drug

    Also called Monotherapy

    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.

Study groups in NCT05322408
Study groupRoleWhat they receive
Administer HCW9218ExperimentalAdminister 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
Receives: Drug: HCW9218

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through study completion, an average of 12 months

Secondary outcomes (7)

  1. 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

    Measured: 3 months after 1st dose

  2. 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

    Measured: 6 months after 1st dose

  3. 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

    Measured: 12 months after 1st dose

  4. Estimate Progression of Overall Survival (OS)

    Estimated with Kaplan-Meier curves

    Measured: 6 months after 1st dose

  5. Estimate Progression Free Survival (PFS)

    Estimated with Kaplan-Meier curves

    Measured: 6 months after 1st dose

  6. Estimate Progression Free Survival (PFS)

    Estimated with Kaplan-Meier curves

    Measured: 1 year after 1st dose

  7. Estimate Progression of Overall Survival (OS)

    Estimated with Kaplan-Meier curves

    Measured: 1 year after 1st dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start1 Apr 2022
  3. Primary completion2 Jan 2025
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05322408
Sponsor's protocol ID
2021LS143
Status last verified
Oct 2025
First submitted
31 Mar 2022
Last updated
5 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HCW9218 in people with Solid Tumor, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Objective of the Dose Finding Component is to Determine the Maximum Tolerated Dose (MTD) of HCW9218 (time frame: through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05322408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.

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