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Recurrent Head and Neck Squamous Cell CarcinomaPhase 1NCT04588038

NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery

A Phase 1 study testing Efineptakin alfa in people with Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, run by Hyunseok Kang, MD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I trial evaluates the side effects of NT-I7 in treating patients with squamous cell carcinoma of head and neck that has come back (recurrent) who are undergoing surgery. NT-I7 is an immunotherapy drug that works by helping the immune system fight tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Efineptakin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
12 Mar 2021to 3 Feb 2025
Phase
Phase 1
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx with recurrent disease which is amenable for curative intent surgical resection
  • Age >= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Absolute neutrophil count >= 1,500/microliter (mcL)
  • Platelets >= 100,000/mcL
  • 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
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  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) =< 3 X institutional upper limit of normal
  • Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT) =< 3 X institutional upper limit of normal
  • Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for subjects with documented liver involvement or bone metastases)
  • Creatinine =< 1.5 x within institutional upper limit of normal OR
  • Creatinine clearance glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2,calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2
  • Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • The effects of NT-I7 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception for the duration of study participation and for 3 months after the study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation for 3 months after the study treatment

Who cannot join

  • Had received immune check point inhibitor within 6 weeks prior to study entry OR chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry)
  • Has history of autoimmune disease which requires active immune suppression (steroid replacement for iatrogenic deficiencies, prednisone 5 mg or less [or equivalent dose], or topical steroids are allowed)
  • Is currently receiving any other investigational agents
  • Has uncontrolled tumor-related pain
  • Has uncontrolled intercurrent medical illness, including but not limited to congestive heart failure, recent acute cardiac event within 6 months, and recent major bleeding event within 6 months
  • Pregnant women are excluded from this study because effects of NT-I7 on developing fetus is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with NT-I7, breastfeeding should be discontinued if the mother is treated with NT-I7
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  • Is not recovered from adverse events (AEs) (other than alopecia, vitiligo, neuropathy or endocrinopathy managed with replacement therapy) due to agents administered more than 4 weeks earlier (i.e., have residual toxicities > grade 1)
  • Had major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to study initiation
  • Had concurrent or previous other malignancy within 5 years of study entry, except noninvasive or indolent malignancy
  • Has spinal cord compression not definitively treated with surgery and/or radiation
  • Has active autoimmune diseases including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis
  • Has active and clinically relevant bacterial, fungal, viral, or Tuberculosis (TB) infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required) or have been hospitalized within 4 weeks prior to NT-I7 injection

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: A Window of Opportunity Trial of NT-I7 in Patients With Locally Recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) Undergoing Salvage Surgery

This phase I trial evaluates the side effects of NT-I7 in treating patients with squamous cell carcinoma of head and neck that has come back (recurrent) who are undergoing surgery. NT-I7 is an immunotherapy drug that works by helping the immune system fight tumor cells. The body produces T-cells which play an important role in body's immune response and its ability to recognize tumor cells. This immunotherapy drug may boost body's T-cells to help fight cancer and enhance body's response to cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate safety and feasibility of a single intramuscular injection of efineptakin alfa (NT-I7) in patients with locally recurrent squamous cell carcinoma of head and neck (SCCHN).

SECONDARY OBJECTIVES:

  1. To describe changes in absolute lymphocyte count (ALC) in peripheral blood after a single dose of NT-I7.

II. To describe changes in tumor infiltrating lymphocytes (TIL) in tumor microenvironment of surgical specimen after a single dose of NT-I7.

III. To evaluate changes in immune subsets in peripheral blood after a single dose of NT-I7 and after surgery.

EXPLORATORY OBJECTIVE:

  1. To make assessment of exploratory biomarkers for pharmacodynamic activity of NT-I7 in peripheral blood, and/or tumor tissue.

OUTLINE:

Patients receive one dose of efineptakin alfa intramuscularly (IM).

After completion of study treatment, patients are followed up for 35 days after dose or 21 days after surgery.

Being tested
Efineptakin alfa
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efineptakin alfaBiological

    Also called GX-I7, Hyleukin-7 (TM), Il-7 Hybrid Fc, IL-7-hyFc

    Given via intramuscular injection

Study groups in NCT04588038
Study groupRoleWhat they receive
Treatment (efineptakin alfa)ExperimentalPatients receive one dose of efineptakin alfa IM.
Receives: Biological: Efineptakin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of treatment-related adverse events

    The proportion of patients experiencing grade 3 or 4 adverse events assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported with exact binomial 95% confidence intervals. Safety analyses will be performed for all patients who receive a dose of NT-I7

    Measured: Up to 35 days after the after the NT-I7 injection

  2. Number of participants who completed course of NT-I7

    Feasibility will be evaluated as the successful completion of pre-operative NT-I7 and proceeding to pre-planned surgery without any extended treatment-related delay defined as > 28 days from day 15. A probability-based decision rule for the study will be used to decide if the probability of successfully proceeding to surgery as planned is convincingly less than .75

    Measured: Up to 43 days after the after the NT-I7 injection

Secondary outcomes (3)

  1. Changes in Absolute lymphocyte count (ALC)

    Descriptive changes in ALC in peripheral blood both before and after a single dose of NT-I7 will be recorded.

    Measured: Up to 36 days after the NT-I7 injection

  2. Changes in Tumor infiltrating lymphocytes (TIL)

    Descriptive changes in tumor infiltrating lymphocytes in tumour microenvironment (TME) after a single dose of NT-I7 in pre-treatment biopsy and surgical specimen will be recorded.

    Measured: Up to 15 days after the NT-I7 injection

  3. Changes in immune phenotyping

    Descriptive changes in immune phenotyping in peripheral blood after a single dose of NT-I7 and after surgery as measured by mass cytometry will be recorded.

    Measured: Up to 36 days after the NT-I7 injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start12 Mar 2021
  3. Primary completion3 Feb 2025
  4. Study completion3 Feb 2025

Why it stopped: Slow Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04588038
Sponsor's protocol ID
202014
Other IDs
NCI-2020-07340
Status last verified
Feb 2025
First submitted
7 Oct 2020
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Efineptakin alfa in people with Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, run by Hyunseok Kang, MD at 1 site in United States.

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 17 inclusion and 12 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: stopped early, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of treatment-related adverse events (time frame: Up to 35 days after the after the NT-I7 injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04588038.

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 14 Feb 2025.

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