A Phase 1/2 interventional study of Addition of Promitil to External Beam Radiotherapy in Head & Neck Squamous Cell Carcinoma and Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by Assuta Ashdod Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Assuta Ashdod Hospital · Phase 1/2, Interventional, and Treatment
This will be an open-label, single-arm, prospective study, in which patients requiring RT for locally and/or regionally advanced head and neck cancers will undergo a combination treatment comprised of intravenously delivered PROMITIL and standard-of-care radiotherapy (RT). The treatment regimen will involve administration of 3 PROMITIL doses, delivered at 21-day intervals, and a course of external beam radiotherapy (EBR), initiated 1-3 days after the first PROMITIL dose. EBR will consist of either standard daily fractionation (5 per week) of up to a total of 70 Gy at 2 Gy/fraction (7 weeks) or a hypofractionated regimen of up to 55 Gy at 2.75 Gy/fraction (HYPNO regimen; 4 weeks), per investigator's preference. PROMITIL will be given by intravenous infusion at a dose of 2 mg/kg body weight with a capped maximal dose of 150 mg. Five sentinel patients (the first five enrolled patients) will be treated with a dose of 1.8 mg/kg body weight for the purpose of conducting a safety analysis to determine tolerability of the dosing regimen prior to enrolling the remaining study patients. Treatment safety will be assessed on a weekly basis, as well as 4 weeks after the last RT treatment. Disease status will be reevaluated 28 days (±7 days) from the end of last radiation treatment by a direct clinical examination. PET CT or CT will be conducted 12 weeks (±7 days) from the end of RT treatment. Thereafter, PET CT and/or CT scans will be repeated every 6 months for the first 24 months, followed by yearly imaging. In addition, during the follow-up phase, the patient will be assessed by a radiation oncologist and/or ENT specialist every 3 months during the first year, every 4 months during the second and third years and every 6 months in years 4 and 5 of observation. A first interim analysis will be conducted 3 months after end of treatment to evaluate safety and response rate. A second interim analysis will be conducted 2 years after end of treatment to evaluate event-free survival (EFS) and delayed toxicities. Final analysis of long-term disease control and survival will be conducted after 5 years.
This will be an open-label, single-arm, prospective study, in which up to 20 adult patients requiring RT for locally and/or regionally advanced head and neck (HN) cancers will undergo a combination treatment of intravenously (IV) delivered PROMITIL and standard of care RT. The treatment regimen will involve administration of 3 PROMITIL doses (2 mg/kg body weight (BW)), delivered at 21-day intervals. In parallel, a course of external beam RT (EBR) will be initiated 1-3 days after the first PROMITIL dose. EBR will consist of either standard daily fractionation (5 per week) of up to a total of 70 Gy at 2 Gy/fraction (7 weeks) or a hypofractionated regimen of up to 55 Gy at 2.75 Gy/fraction (HYPNO regimen; 4 weeks), per investigator's preference. Five sentinel patients (the first 5 enrolled patients) will be treated with a dose of 1.8 mg/kg body weight for the purpose of conducting a safety analysis to determine tolerability of the dosing regimen prior to enrolling the remaining study patients.
Treatment safety will be assessed on a weekly basis throughout the three 21-day treatment courses (43 days total) and, then again 4 weeks after the last RT treatment.
All AEs will be logged for the first 20 weeks of the study. Thereafter, only serious adverse events (SAEs), adverse events of special interest (AESI), new malignancies, death of any cause and pregnancy outcomes will be logged until the end of the long term surveillance period. PROMITL treatment will be discontinued in patients with intolerable toxicity to the combination treatment.
Disease status will be reevaluated 28 days (±7 days) from the end of the last RT treatment fraction by a direct clinical examination. PET-CT or CT will be conducted 12 weeks (±7 days) from the end of RT treatment fraction. Thereafter, PET-CT and/or CT scans will be repeated every 6 months for the first 24 months, followed by yearly imaging. In addition, during the follow-up phase, the patient will be assessed by a radiation oncologist and/or ENT specialist every 3 months during the first year, every 4 months during the second and third years and every 6 months in years 4 and 5 of observation. No other anticancer treatments will be allowed during the treatment period and throughout the follow-up period. Patients with recurrent disease will be withdrawn from the study but followed-up for up to 60 months for survival.
A first interim analysis will be conducted 3 months after end of treatment to evaluate safety and response rate.
A second interim analysis will be conducted 2 years after end of treatment to evaluate event-free survival (EFS) and delayed toxicities. Final analysis of long-term disease control and survival will be conducted after 5 years.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 20 is below the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Assuta Ashdod Hospital is the lead sponsor of 16 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cisplatin-ineligible patients, defined as those meeting one or more of the following criteria:
Renal impairment
Hearing loss/ototoxicity
Neuropathy
Other comorbidities
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment regimen will involve administration of 3 PROMITIL doses, delivered at 21-day intervals, and a course of external beam radiotherapy (EBR), initiated 1-3 days after the first PROMITIL dose. EBR will consist of either standard daily fractionation (5 per week) of up to a total of 70 Gy at 2 Gy/fraction (7 weeks) or a hypofractionated regimen of up to 55 Gy at 2.75 Gy/fraction (HYPNO regimen; 4 weeks), per investigator's preference. PROMITIL will be given by intravenous infusion at a dose of 2 mg/kg body weight with a capped maximal dose of 150 mg. Five sentinel patients (the first five enrolled patients) will be treated with a dose of 1.8 mg/kg body weight for the purpose of conducting a safety analysis to determine tolerability of the dosing regimen prior to enrolling the remaining study patients.
Drug: Addition of Promitil to External Beam Radiotherapy
The treatment regimen will involve administration of 3 PROMITIL doses, delivered at 21-day intervals, and a course of external beam radiotherapy (EBR), initiated 1-3 days after the first PROMITIL dose. EBR will consist of either standard daily fractionation (5 per week) of up to a total of 70 Gy at 2 Gy/fraction (7 weeks) or a hypofractionated regimen of up to 55 Gy at 2.75 Gy/fraction (HYPNO regimen; 4 weeks), per investigator's preference. PROMITIL will be given by intravenous infusion at a dose of 2 mg/kg body weight with a capped maximal dose of 150 mg. Five sentinel patients (the first five enrolled patients) will be treated with a dose of 1.8 mg/kg body weight for the purpose of conducting a safety analysis to determine tolerability of the dosing regimen prior to enrolling the remaining study patients.
Short and Intermediate-Term Safety
To evaluate the short- and intermediate-term safety of PROMITIL in combination with EBR in an adult population with locally or regionally advanced head and neck cancer and to clear a safe dose level for phase 3 studies
Time frame: Two Years
2-year event-free survival (EFS)
To evaluate the 2-year event-free survival (EFS) rate in patients treated with PROMITIL in combination with EBR from the day of the first RT treatment fraction
Time frame: Two years
Long-Term Safety of PROMITIL
To evaluate the long-term safety of PROMITIL in combination with EBR in an adult population with locally or regionally advanced head and neck advanced cancer
Time frame: Five Years
Local-Regional Recurrence-Free Survival (LRFS)
To evaluate local-regional recurrence-free survival (LRFS) (in months) from the day of the first RT treatment fraction.
Time frame: Five Years
Distant Metastasis-Free Survival (DMFS)
To evaluate distant metastasis-free survival (DMFS) (in months) from the day of the first RT treatment fraction.
Time frame: Sixty Months
Time to Recurrence (TTR)
To evaluate time to recurrence (TTR) (in months) from the day of the first RT treatment fraction.
Time frame: 60 months
Overall Survival (OS)
To evaluate overall survival (OS) (in months) from the day of the first RT treatment fraction.
Time frame: Sixty Months
Overall Response Rate (ORR)
To evaluate the overall response rate (ORR) to PROMITIL in combination with EBR
Time frame: Sixty Months
No study locations are listed for this record.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Squamous Cell Carcinoma of Head and Neck →
Assuta Ashdod Hospital