IFx-Hu2.0 + Pembrolizumab for Skin Cancer

Recruiting at 7 trial locations

Overseen By James Bianco, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: TuHURA Biosciences, Inc.

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Active infection, Brain metastases, Chemotherapy, Autoimmune, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 years

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with advanced or metastatic Merkel Cell Carcinoma, a type of skin cancer. Researchers aim to determine if adding IFx-Hu2.0, an experimental treatment, to pembrolizumab can enhance the cancer's response to treatment. Participants will receive either the new combination treatment or a placebo (a harmless, inactive substance) alongside pembrolizumab to compare results. This trial may suit those with unresectable or metastatic Merkel Cell Carcinoma who have not previously received certain immune therapies. As a Phase 2, Phase 3 trial, it evaluates the treatment's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them at least 14 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that IFx-Hu2.0 is generally safe for humans. In earlier studies, patients tolerated this treatment well, meaning it didn't cause major problems. For example, one study found that weekly doses of IFx-Hu2.0 for three weeks were manageable without major issues. Some patients experienced minor side effects, but serious problems were rare. This suggests that IFx-Hu2.0 can be safely combined with other treatments.

The FDA has already approved pembrolizumab for treating some cancers, indicating its safety has been thoroughly tested. However, like many treatments, pembrolizumab can cause side effects, such as tiredness and skin reactions.

Overall, past studies have shown that both IFx-Hu2.0 and pembrolizumab are generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for skin cancer?

Researchers are excited about IFx-Hu2.0 for skin cancer because it introduces a novel approach by combining a targeted intralesional injection with existing immunotherapy. Unlike standard treatments like surgery, radiation, or topical medications, IFx-Hu2.0 is directly injected into the tumor, which might enhance its effectiveness by concentrating the treatment right where it's needed. This method is paired with pembrolizumab, an established immunotherapy, to potentially boost the immune response against the cancer. The unique delivery method and combination with immunotherapy offer hope for improved outcomes in skin cancer treatment.

What evidence suggests that IFx-Hu2.0 might be an effective treatment for skin cancer?

Studies have shown promising results for IFx-Hu2.0 in treating Merkel Cell Carcinoma (MCC), a type of skin cancer. One study found that 56% of MCC patients responded well to IFx-Hu2.0 before receiving additional immune system treatments. Another study reported a 71% response rate when a PD-L1 inhibitor, a specific immune therapy, followed IFx-Hu2.0 treatment. This trial will evaluate IFx-Hu2.0 in combination with Pembrolizumab, a PD-1 inhibitor, to determine if it enhances the effectiveness of immune therapies for people with advanced skin cancer like MCC. These findings offer hope that IFx-Hu2.0 may help the body's immune system fight cancer more effectively. ^{1 2 3 6 7}

Who Is on the Research Team?

Andrew S Brohl, MD

Principal Investigator

Collaborator

Are You a Good Fit for This Trial?

Adults with advanced or metastatic Merkel Cell Carcinoma who haven't been treated with checkpoint inhibitors like Pembrolizumab. They should have a life expectancy of at least six months, an ECOG status ≤2, measurable disease by RECIST v1.1 criteria, and proper organ function.

Inclusion Criteria

My doctor expects me to live six months or more.

I have a tumor that can be injected and is at least 3 mm big.

My cancer can be measured by standard health scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IFx-Hu2.0 or placebo via intralesional injection for 3 weeks, followed by pembrolizumab for up to 2 years

2 years

Weekly visits for 3 weeks, then every 3 weeks for the first year, every 6 weeks for the second year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for progression-free survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• IFx-Hu2.0

Trial Overview The trial is testing IFx-Hu2.0 as an add-on to Pembrolizumab versus a placebo followed by Pembrolizumab in treating Merkel Cell Carcinoma. Participants are randomly assigned to receive either the real drug or placebo through injection into one tumor lesion.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 2 Interventions

Participants randomized to the treatment arm will receive IFx-Hu2.0 (0.1 mg) via intralesional injection in a single lesion once per week for 3 consecutive weeks. Pembrolizumab (200 mg) will be administered intravenously (IV) on Day 1, followed by administration every 3 weeks during the first year of treatment. In the second year, the pembrolizumab dose will be 400 mg every 6 weeks. Pembrolizumab treatment will continue until progressive disease (PD), unacceptable immune-related toxicities, or for a maximum duration of 2 years.

Group II: Control Arm Placebo Group 2 Interventions

Participants randomized to the control arm will receive placebo (0.9% Sodium Chloride Injection, USP) via intralesional injection in a single lesion once per week for 3 consecutive weeks. Pembrolizumab (200 mg) will be administered IV on Day 1, followed by administration every 3 weeks during the first year of treatment. In the second year, the dose will be 400 mg every 6 weeks. Pembrolizumab treatment will continue until PD, unacceptable immune-related toxicities, or for a maximum duration of 2 years.

Who Is Running the Clinical Trial?

TuHURA Biosciences, Inc.

Lead Sponsor

Trials

4

Recruited

40+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.9592

Phase 1b trial of IFx-Hu2.0, a novel in situ cancer vaccine ... Five of 9 (56%) evaluable MCC patients and 1 of 7 (14%) cSCC patients experienced an objective response to this ICI rechallenge, with duration ...

2. targetedonc.com targetedonc.com/view/ifx-hu2-0-a-potential-breakthrough-for-skin-cancers

IFx-Hu2.0: A Potential Breakthrough for Skin Cancers The most promising finding was the 56% response rate to subsequent immunotherapy treatment in patients with MCC. This suggests that IFx-Hu2.0 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04925713

IFx-Hu2.0 for the Treatment of Patients With Skin Cancer This is a multi-site, open-label, interventional, prospective, phase 1 trial to assess safety and tolerability of IFx-Hu2.0 in patients with basal cell ...

4. onclive.com onclive.com/view/dr-brohl-on-the-safety-and-efficacy-of-ifx-hu2-0-in-mcc-and-cscc

Dr Brohl on the Safety and Efficacy of IFx-Hu2.0 in MCC ... However, 71% of patients (n = 7) experienced an objective response with a single-agent PD-L1 inhibitor immediately after completion of IFx-Hu2.0 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11292317/

First-in-Human Stage III/IV Melanoma Clinical Trial of ... In this trial, IFx-Hu2. 0 was shown to be safe to inject into melanoma lesions, and there were no DLTs attributable to IFx-Hu2. 0. The data from clinical trial ...

6. asco.org asco.org/abstracts-presentations/ABSTRACT373040

IFx-Hu2.0 phase I first in human study for unresectable ... 0 demonstrated a favorable safety profile. These data support encouraging immunological correlative responses and further study of IFx-Hu2. 0 as a priming ...

7. tuhurabio.com tuhurabio.com/tuhura-biosciences-inc-initiates-phase-1b-2a-study-of-ifx-hu2-0-as-an-adjunctive-therapy-to-keytruda-pembrolizumab-in-first-line-treatment-for-metastatic-merkel-cell-carcinoma-of-unknown-pri/

TuHURA Biosciences, Inc. Initiates Phase 1b/2a Study of IFx ... We have previously demonstrated that IFx-Hu2.0 can overcome CPI resistance in melanoma, squamous cell, and Merkel cell carcinoma, three ...