NT-I7 (Efineptakin alfa) for Head and Neck Cancer

Overseen By Angelica Valadez

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hyunseok Kang, MD

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: Autoimmune disease, Uncontrolled illness, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new immunotherapy drug, NT-I7 (Efineptakin alfa), for individuals with recurrent head and neck cancer treatable by surgery. The researchers aim to determine if NT-I7 can enhance the immune system's ability to combat cancer cells. It targets those with squamous cell carcinoma in areas such as the mouth or throat who plan to undergo surgery to remove the cancer. For individuals managing this type of recurrent cancer with surgery scheduled, this trial may be suitable. As a Phase 1 trial, the research focuses on understanding how NT-I7 functions in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received an immune checkpoint inhibitor within 6 weeks or chemotherapy, radiation, or surgery within 4 weeks before the study. Please consult with the trial team for specific guidance on your medications.

Is there any evidence suggesting that NT-I7 (Efineptakin alfa) is likely to be safe for humans?

Research has shown that efineptakin alfa, also known as NT-I7, is under evaluation for its safety and effectiveness in treating cancers. Evidence suggests that NT-I7 is a safe drug that boosts the body's T-cells, which are crucial for fighting cancer. In studies involving other tumor types, NT-I7 was well-tolerated, with most participants not experiencing severe side effects.

Although specific safety information for head and neck cancer remains undetailed, ongoing research is assessing the safety and practicality of administering a single dose of NT-I7 to patients with recurring squamous cell carcinoma. So far, studies have demonstrated that it activates the immune system without causing major issues. This indicates that NT-I7 could be a promising and safe option to help the body fight cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for head and neck cancer, which often include surgery, radiation, and chemotherapy, efineptakin alfa offers a novel approach by boosting the immune system. This treatment is unique because it uses a new active ingredient, efineptakin alfa, which is designed to enhance the body's natural ability to fight cancer cells by stimulating the production of immune cells. Researchers are excited about this treatment because it represents a potential shift towards immunotherapy, which aims to harness the body's own defenses rather than relying solely on external methods like radiation or drugs. This could lead to more targeted and potentially less toxic treatment options for patients.

What evidence suggests that NT-I7 might be an effective treatment for head and neck cancer?

Research has shown that NT-I7 (Efineptakin alfa), the treatment under study in this trial, can increase T-cells, which play a crucial role in the immune system's fight against cancer. Early laboratory studies demonstrated that NT-I7 strengthens the body's defense against head and neck cancer cells, suggesting its potential effectiveness. In cancer research models, NT-I7 improved survival rates, indicating it might help the body attack tumor cells more effectively. Although detailed information from human studies remains limited, these early results are promising for its potential use in treating recurrent head and neck cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Hyunseok Kang

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Adults with recurrent squamous cell carcinoma of the head and neck, suitable for surgery, can join this trial. They must have proper liver and kidney function, no severe autoimmune diseases or recent major health events like heart failure. HIV-positive participants are eligible if their viral load is undetectable. Participants must not be pregnant or breastfeeding and agree to use contraception.

Inclusion Criteria

Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits

Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) =< 3 X institutional upper limit of normal

I had hepatitis C but am cured, or I'm being treated with no detectable virus.

Exclusion Criteria

I have an active autoimmune disease such as lupus, rheumatoid arthritis, or multiple sclerosis.

I haven't had immune therapy in the last 6 weeks or chemo, radiation, or surgery in the last 4 weeks.

I do not have any active infections like TB, Hepatitis, or HIV, and haven't been hospitalized in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular dose of efineptakin alfa (NT-I7)

1 day

Surgery

Participants undergo salvage surgery for recurrent squamous cell carcinoma of head and neck

Up to 28 days after NT-I7 injection

Follow-up

Participants are monitored for safety and effectiveness after treatment and surgery

35 days after NT-I7 dose or 21 days after surgery

What Are the Treatments Tested in This Trial?

Interventions

• Efineptakin alfa

Trial Overview

The trial tests NT-I7 (Efineptakin alfa), an immunotherapy drug designed to boost T-cells in the immune system to better fight cancer cells. It's given to patients whose head and neck cancer has returned, alongside their surgical treatment.

How Is the Trial Designed?

Group I: Treatment (efineptakin alfa) Experimental Treatment 1 Intervention

Patients receive one dose of efineptakin alfa IM.

Who Is Running the Clinical Trial?

Hyunseok Kang, MD

Lead Sponsor

Trials

2

Recruited

20+

NeoImmuneTech

Industry Sponsor

Trials

16

Recruited

780+

Published Research Related to This Trial

In a study involving 204 patients with locally advanced squamous cell carcinoma of the head and neck, adding erlotinib to standard cisplatin and radiotherapy did not significantly improve the complete response rate (CRR) or progression-free survival (PFS) compared to cisplatin and radiotherapy alone.

While patients receiving erlotinib experienced more skin rash, the overall toxicity levels were similar between the two treatment groups, indicating that erlotinib did not increase the safety risks associated with the standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cisplatin and radiotherapy with or without erlotinib in locally advanced squamous cell carcinoma of the head and neck: a randomized phase II trial. Martins, RG., Parvathaneni, U., Bauman, JE., et al.[2022]

In a phase 2 study involving 103 patients with recurrent/metastatic squamous cell carcinoma of the head and neck, the addition of panitumumab to docetaxel/cisplatin chemotherapy improved progression-free survival (PFS) to 6.9 months compared to 5.5 months for chemotherapy alone.

While the combination therapy showed a higher overall response rate (44% vs. 37%), it also resulted in a higher incidence of grade 3/4 adverse events (73% vs. 56%), indicating a trade-off between efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PARTNER: An open-label, randomized, phase 2 study of docetaxel/cisplatin chemotherapy with or without panitumumab as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck. Wirth, LJ., Dakhil, S., Kornek, G., et al.[2019]

In a study of 118 patients with locally advanced nasopharyngeal carcinoma, the combination of nimotuzumab and cisplatin plus 5-fluorouracil (NPF) showed a higher response rate for cervical lymph nodes (81% vs 60%) compared to docetaxel and PF (DPF).

The NPF regimen resulted in significantly fewer adverse reactions, such as leukopenia and gastrointestinal issues, and improved tolerance during concurrent radiotherapy and chemotherapy, indicating a safer treatment option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of nimotuzumab combined with cisplatin plus 5-fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy: a multicenter randomized controlled study. Lu, Y., Chen, D., Liang, J., et al.[2020]

Cisplatin remains the primary chemotherapy agent for treating recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN), often used in combination with 5-FU, while taxanes are being explored for their potential benefits in treatment regimens.

The EGFR-directed monoclonal antibody cetuximab has shown effectiveness in combination with chemotherapy for recurrent/metastatic SCCHN and may also be beneficial as a single agent in platinum-resistant cases, highlighting the potential of targeted therapies in this cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New approaches to enhance chemotherapy in SCCHN. Bourhis, J.[2020]

In a study of 22 Japanese patients with inoperable recurrent or metastatic squamous cell carcinoma of the head and neck, the modified TPEx treatment showed a 55% overall response rate and median overall survival of 14.3 months.

Prophylactic granulocyte colony-stimulating factor (G-CSF) significantly reduced the incidence of severe neutropenia, highlighting its importance in managing treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified TPEx as First-line Treatment for Recurrent and/or Metastatic Head and Neck Cancer. Suzuki, M., Takenaka, Y., Kishikawa, T., et al.[2021]

In a phase I study involving 35 patients with locally advanced squamous cell carcinoma of the head and neck, cabazitaxel combined with cisplatin and 5-fluorouracil showed a recommended phase II dose of 22.5 mg/m2, with manageable toxicity at lower doses of cisplatin.

The treatment resulted in an overall response rate of 57.6%, with a median progression-free survival of approximately 58% at 3 years, indicating promising efficacy for this combination therapy in a challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I study of cabazitaxel in combination with platinum and 5-fluorouracil (PF) in locally advanced squamous cell carcinoma of head and neck (LA-SCCHN). Camille, N., Rozehnal, J., Roy, E., et al.[2019]

In a phase 3 trial involving 657 patients with recurrent or metastatic squamous-cell carcinoma of the head and neck, the addition of panitumumab to chemotherapy improved progression-free survival (5.8 months vs. 4.6 months) but did not significantly enhance overall survival compared to chemotherapy alone.

The study found that p16 status may serve as a prognostic and predictive biomarker, with p16-negative patients experiencing longer overall survival with panitumumab compared to the control group, suggesting that p16 status could help tailor treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Vermorken, JB., Stöhlmacher-Williams, J., Davidenko, I., et al.[2022]

The combination of cetuximab (Cet) with the TPF chemotherapy regimen (docetaxel, cisplatin, and fluorouracil) significantly reduced tumor volume and improved histological responses in a mouse model of advanced head and neck cancer, indicating strong anti-tumor activity.

Adding bevacizumab (Bev) to the TPF-Cet combination did not provide additional benefits over the TPF-Cet treatment alone, suggesting that TPF-Cet is a highly effective option for managing advanced head and neck tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor activity of cetuximab associated with the taxotere-cisplatin-fluorouracil (TPF) combination on an orthotopic head and neck cancer model. Bozec, A., Sudaka, A., Etienne-Grimaldi, MC., et al.[2018]

In a study of 134 patients with recurrent and/or metastatic head and neck cancer, the addition of cetuximab (Cx) to platinum-based and 5-fluorouracil chemotherapy (PFU) significantly improved progression-free survival (PFS) from 4.4 months to 6.1 months.

The presence of the KRAS-LCS6 variant did not have a prognostic impact on treatment outcomes, indicating that the PFU+Cx combination may be beneficial for all patients regardless of their KRAS variant status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of cetuximab addition to a platinum-fluorouracil-based chemotherapy according to KRAS-LCS6 variant in an unselected population of recurrent and/or metastatic head and neck cancers. Bastit, V., Bon-Mardion, N., Picquenot, JM., et al.[2021]

PD-1 inhibitors, used for treating recurrent or metastatic squamous cell carcinoma of the head and neck, can lead to immune-mediated adverse reactions (IMARs), highlighting the importance of monitoring patients closely.

Nurses play a crucial role in mapping patients' baseline profiles and educating them about IMARs, which helps in the timely diagnosis and management of these reactions, ultimately supporting the continuation of effective PD-1 immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PD-1 Inhibitors: Safety of Use and Management of Immune-Mediated Adverse Reactions in Patients With Head and Neck Cancer. Lewis, RL., Miller, KL.[2020]

The addition of monoclonal antibodies against the epidermal growth factor receptor (EGFR) to standard chemotherapy drugs (cisplatin, 5-FU, and docetaxel) may enhance the response rate in treating head and neck cancer, as suggested by recent studies.

This study utilized squamous cell cancer lines transplanted into nude mice to evaluate the effectiveness of these treatments, indicating a potential for improved remission rates with the combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EGFR-antibody-supplemented TPF chemotherapy. Preclinical investigations to a novel approach for head and neck cancer induction treatment. Knecht, R., Peters, S., Hambek, M., et al.[2018]

Anti-EGFR antibody therapy has been shown to improve survival rates in patients with locally advanced head and neck cancer when combined with radiation, based on Phase II-III studies.

In recurrent or metastatic head and neck cancer, anti-EGFR antibody therapy combined with chemotherapy significantly increased remission rates without adding extra toxicity, indicating a promising treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of targeted therapy in the treatment of squamous cell head and neck cancer]. Gyergyay, F.[2018]

In a phase 2 trial involving 152 patients with locally advanced squamous-cell carcinoma of the head and neck, the combination of chemoradiotherapy showed better local-regional control at 2 years (61%) compared to radiotherapy plus panitumumab (51%).

The study found that while both treatment groups experienced significant adverse events, the rates of serious adverse events were similar, suggesting that panitumumab does not provide a sufficient benefit to replace cisplatin in this treatment setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panitumumab plus radiotherapy versus chemoradiotherapy in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-2): a randomised, controlled, open-label phase 2 trial. Giralt, J., Trigo, J., Nuyts, S., et al.[2022]

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NT-I7 (Efineptakin alfa) for Head and Neck Cancer

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Preliminary data demonstrate safety and activity of IL-7 in patients with KS and activity specifically among individuals HIV-associated KS.

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Findings suggest GX-I7 is a safe T cell-amplifying agent with peripheral immune activation. Ongoing studies are exploring its ability to enhance immune ...