IFx-Hu2.0 for the Treatment of Patients With Skin Cancer

NCT04925713 | Completed Phase 1 Results FDA Drug

• 1 other identifier: SC 2020-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

One hundred patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion. These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-5 days) for any delayed adverse events..

Conditions

Cutaneous Squamous Cell Carcinoma; Basal Cell Carcinoma

Keywords

cSCC; BCC; pAc/emm55; IFx-Hu2.0; Gene Therapy; Immunotherapy; Oncology; Immunology; plasmid DNA

Outcome Measures

Primary Outcomes (2)

• Rate of Adverse Events

  Rate of Adverse Events reported per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  28 days post injection

• Number of Patients Who Completed the Trial [Time Frame: 28 Days Post Injection]

  Number of Patients who completed the trial per protocol without major deviations.

  28 days post injection

Study Arms (1)

IFx-Hu2.0 (plasmid DNA) 0.1 mg/lesion

EXPERIMENTAL

One hundred (100) patients will receive 0.1 mg of IFx-Hu2.0 injected intratumorally in a single lesion at a single time point and be followed-up 28 days thereafter.

Biological: IFx-Hu2.0

Interventions

IFx-Hu2.0 BIOLOGICAL

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 lymph 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.

Also known as: pAc/emm55

IFx-Hu2.0 (plasmid DNA) 0.1 mg/lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Ability to receive intralesional injections
• Male or female, aged ≥ 18 years
• Histologically confirmed cutaneous squamous cell carcinoma, or basal cell carcinoma with accessible lesions (based on archival tissue or new tissue biopsy for histological confirmation)
• Life expectancy of at least 24 weeks at the time of screening
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Must have measurable disease greater than 3 mm
• At least one injectable lesion
• Adequate organ function as defined below (Note: these screening laboratory tests must be obtained within two weeks prior to the baseline visit, Day 0):
• Hemoglobin (Hb) \>10 g/dL 10.2. Absolute Neutrophil Count (ANC) \>1,500 cells/mcL 10.3. Platelet Count (PLT) \>75,000/mcL 10.4. Prothrombin Time (PT) or International Normalized Ratio (INR) ≤1.5 times the institutional ULN unless patient is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of the intended use of anticoagulants.
• Activated Partial Thromboplastin Time (aPTT) ≤1.5 times the institutional ULN unless patient is receiving anticoagulant therapy as long as aPTT is within therapeutic range of the intended use of anticoagulants.
• Serum Creatinine (SCr) ≤1.5 times the institutional ULN 10.7. Total Bilirubin ≤1.5 times the institutional ULN 10.8. Aspartate Aminotransferase (AST) ≤3 times the institutional ULN 10.9. Alanine Aminotransferase (ALT) ≤3 times the institutional ULN 10.10. Lactate Dehydrogenase (LDH) ≤2 times the institutional ULN 10.11. Alkaline Phosphatase (ALP) ≤2.5 times the institutional ULN 10.12. Gamma GT (GGT) ≤2.5 times the institutional ULN
• Lymphocyte count ≥500,000 cells/mL
• For females of reproductive potential: must have a negative urine or serum pregnancy test result within 24 hours prior to receiving IFx-Hu2.0; must use highly effective contraception (e.g.,licensed hormonal or barrier methods) for at least one month prior to screening and agreement to use such a method during study participation and for an additional 26 weeks after the end of study treatment

You may not qualify if:

• Concurrent participation in any other clinical trial
• Inability to consent for self
• Lesions on scalp with bone erosions must not be selected as injection sites for IFx-Hu2.0
• Life expectancy of fewer than 24 weeks at the time of screening
• Prior systemic anti-cancer treatment within three weeks from start of treatment (Day 0)
• Treatment with any investigational product within the three weeks preceding injection
• Concurrent chemotherapy or biological therapy. Concurrent radiotherapy is allowed as long as it is not the same site as the injected lesion.
• Current treatment with systemic immunosuppressive corticosteroid (greater than 10 mg of daily prednisone) doses or other immunosuppressants such as those needed for solid organ transplants. Medications needed to treat conditions such as reactive airway disease are not excluded.
• Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 26 weeks after the last dose of trial treatment
• Immunizations for encapsulated bacteria were not given for patients who have undergone a splenectomy
• Serious underlying medical or psychiatric conditions, active infections requiring the use of antimicrobial drugs, or active bleeding that would make the subject unsuitable or unable to participate in the study
• Active Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) or Hepatitis B/C. Patients with treated HIV/AIDS or Hepatitis B/C with no evidence of active infection may be enrolled
• History of organ allograft transplantation
• Presence of any uncontrolled and significant medical or psychiatric condition which would interfere with trial safety assessments

Sponsors & Collaborators

• TuHURA Biosciences, Inc.: lead

Study Sites (1)

Moore Clinical Research

Brandon, Florida, 33716, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell

Results Point of Contact

• Title: James Bianco, MD - Chief Executive Officer
• Organization: Morphogenesis, Inc

jbianco@morphogenesis-inc.com

8138756600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 14, 2021
• Study Start: June 10, 2021
• Primary Completion: October 7, 2021
• Study Completion: March 10, 2022
• Last Updated: August 2, 2024
• Results First Posted: August 2, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)