Cutaneous Melanoma, Stage IIINCT04853602
IFx-Hu2.0 Expanded Access Program
A study testing IFx-Hu2.0 in people with Cutaneous Melanoma, Stage III and Cutaneous Melanoma, Stage IV, run by TuHURA Biosciences, Inc..
Trial summary
Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma, advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC) who have failed all available treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV, Merkel Cell Carcinoma
- What is being tested?
- IFx-Hu2.0
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- To request more information use Responsible Party contact information provided in this record
Who cannot join
- To request more information use Responsible Party contact information provided in this record
Trial locations and contacts
No sites are listed yet.
About this study
Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma, advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC) who have failed all available treatment options.
To request access, use Responsible Party contact information provided in this record..
- Conditions
- Cutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
- Being tested
- IFx-Hu2.0
- Keywords
- CM, MCC, cSCC, pDNA, plasmid DNA, pAc/emm55, IFx-Hu.20, Immunotherapy, Gene Therapy, Immunology, Oncology, Immuno-Oncology
- Medical subject headings
- Melanoma, Carcinoma, Merkel Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFx-Hu2.0Biological
Also called pAc/emm55
The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer.
Therapeutic Classification:
- Immunomodulatory Agent
Route of Administration:
- Intralesional (i.e. injection of cutaneous, subcutaneous or nodal lesions)
Mechanism of Action:
- Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells.
Physiological Effect:
- Expression of the emm55 gene by the tumor cells triggers immune recognition of tumor-specific and -associated antigens which leads to innate and adaptive immune responses. In addition to priming anti-tumor immunity in immune checkpoint inhibitor (ICI)-naïve patients, this could re-sensitize patients with primary or secondary ICI clinical resistance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Melanoma, Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- TuHURA Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853602
- Sponsor's protocol ID
- IFx-Hu2.0 Expanded Access
- Status last verified
- Aug 2024
- First submitted
- 16 Apr 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
Publications
Bunch BL, Kodumudi KN, Scott E, Morse J, Weber AM, Berglund AE, Pilon-Thomas S, Markowitz J. Anti-tumor efficacy of plasmid encoding emm55 in a murine melanoma model. Cancer Immunol Immunother. 2020 Dec;69(12):2465-2476. doi: 10.1007/s00262-020-02634-4. Epub 2020 Jun 18.
PubMed 32556443
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IFx-Hu2.0 Expanded Access Program
- ClinicalTrials.gov ID
- NCT04853602
- Acronym / sponsor ID
- IFx-Hu2.0 Expanded Access
- Conditions
- Cutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
- Keywords
- CM, MCC, cSCC, pDNA, plasmid DNA, pAc/emm55, IFx-Hu.20, Immunotherapy
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- TuHURA Biosciences, Inc.Industry (pharma, biotech, devices)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma, advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC) who have failed all available treatment options.
To request access, use Responsible Party contact information provided in this record..
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To request more information use Responsible Party contact information provided in this record
Key exclusion criteria (1 listed)
- To request more information use Responsible Party contact information provided in this record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFx-Hu2.0Also: pAc/emm55The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer. Therapeutic Classification: * Immunomodulatory Agent Route of Administration: * Intralesional (i.e. injection of cutaneous, subcutaneous or nodal lesions) Mechanism of Action: * Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells. Physiological Effect: * Expression of the emm55 gene by the tumor cells triggers immune recognition of tumor-specific and -associated antigens which leads to innate and adaptive immune responses. In addition to priming anti-tumor immunity in immune checkpoint inhibitor (ICI)-naïve patients, this could re-sensitize patients with primary or secondary ICI clinical resistance. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Background: PubMed 32556443Bunch BL, Kodumudi KN, Scott E, Morse J, Weber AM, Berglund AE, Pilon-Thomas S, Markowitz J. Anti-tumor efficacy of plasmid encoding emm55 in a murine melanoma model. Cancer Immunol Immunother. 2020 Dec;69(12):2465-2476. doi: 10.1007/s00262-020-02634-4. Epub 2020 Jun 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing IFx-Hu2.0 in people with Cutaneous Melanoma, Stage III and Cutaneous Melanoma, Stage IV, run by TuHURA Biosciences, Inc..
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James A Bianco, MD (813-875-6600 ext. 104, jbianco@tuhurabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853602, which also lists 1 linked publication.
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 12 Aug 2024.