IFx-Hu2.0 + Pembrolizumab for Merkel Cell Carcinoma

Recruiting at 1 trial location

Overseen By James Bianco, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: TuHURA Biosciences, Inc.

Must not be taking: Corticosteroids, Immunosuppressives

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

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 4

Duration: 6 months

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for Merkel Cell Carcinoma, a rare and aggressive skin cancer. It aims to determine if adding IFx-Hu2.0, an experimental treatment, to pembrolizumab, a type of immunotherapy, is safe and feasible for patients with advanced stages of this cancer. Participants will receive injections directly into a tumor, followed by pembrolizumab infusions. This trial may suit individuals with advanced Merkel Cell Carcinoma that cannot be surgically removed and who have not previously received checkpoint inhibitors like pembrolizumab. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

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

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

A previous study found IFx-Hu2.0 to be safe for patients, with no serious side effects reported. About 33% of patients experienced mild side effects, such as redness or swelling, suggesting that IFx-Hu2.0 is generally well-tolerated when used alone.

Pembrolizumab has also proven safe for most people. Another study reported rare cases of immune-related lung issues, but most patients did not experience severe side effects. Pembrolizumab is already approved for treating Merkel cell carcinoma (a type of skin cancer) and has been used safely by many patients.

Overall, past research indicates that both treatments are safe for patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for Merkel Cell Carcinoma focus on using immune checkpoint inhibitors like pembrolizumab to help the immune system attack cancer cells. But the new treatment, IFx-Hu2.0, works differently by being directly injected into the tumor, which may enhance the immune response precisely where it's needed. This localized approach could potentially improve effectiveness while minimizing systemic side effects. Researchers are excited about the possibility that combining IFx-Hu2.0 with pembrolizumab could lead to more robust and targeted immune responses, offering new hope for patients with this aggressive skin cancer.

What evidence suggests that IFx-Hu2.0 and pembrolizumab could be effective for Merkel Cell Carcinoma?

Research has shown that pembrolizumab effectively treats various cancers, including Merkel cell carcinoma, by helping the immune system target and combat cancer cells more effectively. In this trial, participants will receive a combination of IFx-Hu2.0 and pembrolizumab. Early studies of IFx-Hu2.0 with pembrolizumab have shown promise in enhancing the immune response to cancer cells. This combination aims to overcome resistance to standard treatments and improve patient outcomes. Initial findings suggest that adding IFx-Hu2.0 may enhance pembrolizumab's effectiveness by promoting a stronger attack on tumors. ^{2 3 5 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 (MCC) who haven't been treated with CPI drugs like Pembrolizumab before. They should have a life expectancy of at least six months, be able to perform daily activities (ECOG ≤ 2), and have measurable disease by scans. Their cancer must be stage III/IV and they need at least one lesion suitable for injection.

Inclusion Criteria

My doctor expects me to live six months or more.

My cancer can be measured on scans.

I can take care of myself but might not be able to do heavy physical work.

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 as a visceral lesion injection once per week for three weeks, followed by pembrolizumab every three weeks for approximately six months

6 months

Weekly visits for 3 weeks, then every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• IFx-Hu2.0
• Pembrolizumab

Trial Overview The trial is testing IFx-Hu2.0 as an additional treatment alongside Pembrolizumab in patients with MCC. Nine participants will receive an injection of IFx-Hu2.0 directly into a tumor lesion followed by standard treatment with Pembrolizumab.

How Is the Trial Designed?

Group I: IFx-Hu2.0 Experimental Treatment 2 Interventions

Subjects will receive IFx-Hu2.0 (0.1 mg) as a visceral lesion injection in a single lesion once per week for three consecutive weeks. KEYTRUDA® (pembrolizumab) (200 mg) will be administered intravenously (IV) on Visit 1 (within 48 hours from the first IFx-Hu2.0 injection) then every three weeks for approximately six months, until disease progression or unacceptable immune related toxicity.

Who Is Running the Clinical Trial?

TuHURA Biosciences, Inc.

Lead Sponsor

Trials

4

Recruited

40+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06940440

IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In ... This Phase 1, multicenter, open-label trial will assess the safety and feasibility of IFx-Hu2.0 as adjunctive therapy to pembrolizumab in adult patients (≥18 ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS9603

naïve patients with advanced or metastatic Merkel cell ... A randomized, double-blind, placebo-controlled trial to evaluate the potential for adjunctive IFx and pembro to improve response rates in the first-line ...

3. targetedonc.com targetedonc.com/view/ifx-hu2-0-enters-clinical-trials-for-merkel-cell-carcinoma

IFx-Hu2.0 Enters Clinical Trials for Merkel Cell Carcinoma Trials of IFx-Hu2.0 are initiating, looking to overcome checkpoint inhibitor resistance in Merkel cell carcinoma.

4. 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 ... Phase 1b/2a trial designed to evaluate the safety and feasibility of IFx-Hu2.0 in combination with Keytruda when administered via Interventional Radiology (IR)

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293985/

Current Trends in Clinical Trials for Merkel Cell Carcinoma ... Early-phase studies of IFx-Hu2.0 demonstrated systemic antitumor immune responses in MCC, and a phase III trial combining intratumoral IFx-Hu2.0 ...

6. 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 ... IT IFx-Hu2.0 is safe and feasible to administer at weekly dosing repeated up to 3 weeks. An unplanned exploratory analysis revealed frequent (56%) and durable ...

7. 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 ... No grade 2 or higher treatment-related adverse effects (TRAEs) were reported. Grade 1 TRAEs were experienced by 33% of patients, including 2 ...