A Phase 1 interventional study of RPH-002 and Erbitux® in Head and Neck Squamous Cell Carcinoma, sponsored by R-Pharm. Completed at 18 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by R-Pharm · Phase 1, Interventional, and Treatment
Among 86 studies testing cetuximab in Squamous Cell Carcinoma of Head and Neck — 11 open to participants now, 19 under way, 7 of them phase 3. Cetuximab · Squamous Cell Carcinoma of Head and Neck.
Among the 86 studies testing cetuximab in Squamous Cell Carcinoma of Head and Neck, this one is the 17th largest by enrollment of the 84 interventional ones, is one of 3 that started in 2020, is one of 16 in phase 1, and was the 84th registered.
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 enrollment of 118 is above 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 →11 of the 86 studies testing cetuximab in Squamous Cell Carcinoma of Head and Neck are open now, in 4 countries. Each count lists the studies.
Cetuximab: first FDA approval 2004 (ERBITUX), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 434 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 310 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →86 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 3 started in 2020.
Median enrollment 46 across the 84 interventional studies. Of the 59 that completed or were terminated, 32 (54%) have results posted.
11 of 86 have an industry lead sponsor. The 10 most frequent:
R-Pharm is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
R-Pharm has 3 studies filed under Squamous Cell Carcinoma of Head and Neck — fewer than ten, so there is no comparison to draw.
4 of the studies testing cetuximab in Squamous Cell Carcinoma of Head and Neck that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04375384Wake Forest University Health SciencesCetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer | 2026-12 |
| NCT06978829Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityCetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC | 2027-03-31 |
| NCT04722523Memorial Sloan Kettering Cancer CenterA Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer | 2027-06-20 |
| NCT06869473Gruppo Oncologico del Nord-OvestCetuximab Plus Platinum and Taxane-based Chemotherapy, Followed by Avelumab and Cetuximab, as First-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With a PD-L1 Combined Positive Score (CPS)≥1≤19. | 2027-08-20 |
Among the 86 studies testing cetuximab in Squamous Cell Carcinoma of Head and Neck, from their registry updates:
The primary objective of this clinical study is to compare the pharmacokinetic parameters of drugs RPH-002 and Erbitux® after a single intravenous administration, as well as to evaluate the safety of drug RPH-002 in comparison with drug Erbitux® when used in combination with Docetaxel and Cisplatin as first-line therapy in patients with Recurrent Head and Neck Squamous Cell Carcinoma. In addition, this study will include a comparative assessment of immunogenicity and a pilot evaluation of efficacy
This study is a multicenter, open-label, randomized Phase I study
This clinical study includes the following stages:
Therapy with cetuximab within this clinical study will continue until disease progression or the development of unacceptable toxicity
Disease progression is defined as the presence of one or more of the following criteria:
The maximum duration of therapy with cetuximab within the study will be 54 weeks
The study will include the following periods:
Screening Period 1 (up to 15 days)
Includes Days -14 to 0 (prior to the first administration of the investigational product/comparator)
Main Period (Period 1)
The main study period includes Days 1-126
Patients will be randomized in a 1:1 ratio into one of two study groups: RPH-002 and Erbitux®. Patients will receive combination therapy with RPH-002 or Erbitux®, docetaxel, and cisplatin for 18 weeks, or until the development of unacceptable toxicity or disease progression
The Main Period includes collection of data on complaints and symptoms, physical examination, assessment of vital signs (body temperature, blood pressure, pulse), monitoring of laboratory parameters (hematology, serum biochemistry, coagulation tests, blood analysis, and urinalysis), blood sampling for determination of serum cetuximab concentration and immunogenicity assessment, ECG, and evaluation of Karnofsky performance status. Tumor response assessment will be performed every 6 weeks during Period 1
Screening Period 2 (up to 8 days)
Includes Days -7 to 0 (prior to Visit 1 of the Maintenance Therapy Period). During Screening Period 2, the patient's general condition and laboratory and instrumental test results will be evaluated to determine eligibility for continuation of therapy in the Maintenance Therapy Period
Maintenance Therapy Period (Period 2)
Days 127-386
Patients eligible for the Maintenance Therapy Period will be those who have achieved stable disease or an objective tumor response according to RECIST 1.1 at Week 18 of the Main Period
During the Maintenance Therapy Period, patients will receive monotherapy with RPH-002 or Erbitux® at the same dose regimen (250 mg/m²) once weekly. The maximum number of administrations of cetuximab during this period will be 36
Treatment during this period will continue until the earliest of the following:
The Period includes collection of data on complaints and symptoms, physical examination, assessment of vital signs (body temperature, blood pressure, pulse), monitoring of laboratory parameters (hematology, serum biochemistry, coagulation tests, and urinalysis), collection of biological samples for immunogenicity analysis, ECG, and evaluation of Karnofsky performance status. Tumor response assessment will be performed every 6 weeks during Period 2
This study period includes safety evaluation of the investigational therapy in all patients who completed Period 1 and did not enter Period 2, as well as all patients who completed therapy during Period 2. The follow-up visit will be conducted 28 ± 3 days after the last administration of the study treatment
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.
Main Period (Period 1)
Screening laboratory values within the following limits (per local lab normal ranges):
Maintenance Therapy Period (Period 2)
Laboratory values within the following limits (per local lab normal ranges):
Exclusion Criteria:
Main Period (Period 1)
Maintenance Therapy Period (Period 2)
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Patients receive RPH-002 in combination with docetaxel and cisplatin during the Main Period (up to 18 weeks, 6 cycles) and RPH-002 monotherapy during the Maintenance Period (up to 36 weeks), or until disease progression or unacceptable toxicity
Drug: RPH-002 · Drug: cisplatin · Drug: docetaxel
Patients receive Erbitux® in combination with docetaxel and cisplatin during the Main Period (up to 18 weeks, 6 cycles) and Erbitux® monotherapy during the Maintenance Period (up to 36 weeks), or until disease progression or unacceptable toxicity
Drug: Erbitux® · Drug: cisplatin · Drug: docetaxel
RPH-002: solution for infusion, 5 mg/mL RPH-002 is administered IV once weekly. The first dose is 400 mg/m², given as a 20 mg/m² IV test dose over 10 minutes followed by 380 mg/m² IV over the remainder of 120 minutes. Subsequent weekly doses are 250 mg/m² IV over 60 minutes Thirty to sixty minutes prior to the infusion of RPH-002, premedication with diphenhydramine 50 mg (or other H1-receptor antagonist) administered orally or intravenously and a glucocorticosteroid (e.g., dexamethasone 8 mg) is required
Also known as: cetuximab
Erbitux®: solution for infusion, 5 mg/mL Erbitux® is administered IV once weekly. The first dose is 400 mg/m², given as a 20 mg/m² IV test dose over 10 minutes followed by 380 mg/m² IV over the remainder of 120 minutes. Subsequent weekly doses are 250 mg/m² IV over 60 minutes Thirty to sixty minutes prior to the infusion of Erbitux®, premedication with diphenhydramine 50 mg (or other H1-receptor antagonist) administered orally or intravenously and a glucocorticosteroid (e.g., dexamethasone 8 mg) is required
Also known as: cetuximab
Solution for injection (500 μg / 1 mg / 1 mL; 10 / 25 / 50 / 100 mg per vial) Cisplatin is administered intravenously at 75 mg/m² once every 3 weeks. Hydration is required to promote diuresis and reduce cisplatin-related nephrotoxicity
Concentrate for solution for infusion (40 mg/mL; 0.5 mL / 2 mL per vial) Docetaxel is administered intravenously at 75 mg/m² over 60 minutes once every 3 weeks, prior to the cisplatin infusion and concurrently with prehydration
Area under the pharmacokinetic curve "concentration-time" (AUC(0-168)) of cetuximab
Area under the pharmacokinetic curve "concentration-time" of cetuximab after the first (single dose) administration, truncated at the point before the second administration, i.e. up to 168 hours
Time frame: Pre-dose on Day 1 (first administration) and 1, 2, 3, 4, 6, 12, 24, 48, 96, 168 hours post-dose
Proportion of patients (%) with adverse drug reactions (ADRs) of any severity
Proportion of patients (%) with adverse drug reactions (ADRs) of any severity
Time frame: Up to Day 365
Maximum serum concentration of cetuximab after the first administration (Cmax)
Maximum serum concentration of cetuximab after the first administration (Cmax)
Time frame: Pre-dose on Day 1 (first administration) and 1, 2, 3, 4, 6, 12, 24, 48, 96, 168 hours post-dose
Maximum serum concentration of cetuximab at steady state (Cmax ss)
Maximum serum concentration of cetuximab at steady state (Cmax ss)
Time frame: Pre-dose on Day 22 (fourth infusion) and 1, 2, 3, 4, 6, 12, 24, 168 hours post-dose
Minimum serum concentration of cetuximab at steady state (Cmin ss)
Minimum serum concentration of cetuximab at steady state (Cmin ss)
Time frame: Within 30 ± 10 minutes prior to dosing at Visits 3 (Day 15), 5 (Day 29), 6 (Day 36), 7 (Day 43), 8 (Day 50), 9 (Day 57), 12 (Day 78), 15 (Day 99), and 18 (Day 120)
Area under the pharmacokinetic curve "concentration-time" of cetuximab at steady state (AUC tau)
Area under the pharmacokinetic curve "concentration-time" of cetuximab at steady state (AUC tau ss)
Time frame: Pre-dose on Day 22 (fourth infusion) and 1, 2, 3, 4, 6, 12, 24, 168 hours post-dose
Proportion of patients (%) with adverse events (AEs) of any severity
Proportion of patients (%) with adverse events (AEs) of any severity
Time frame: Up to Day 365
Proportion of patients (%) with AEs of severity grade ≥ 3
Proportion of patients (%) with AEs of severity grade ≥ 3 according to CTCAE 5.0
Time frame: Up to Day 365
Proportion of patients (%) with serious adverse events (SAEs)
Proportion of patients (%) with SAEs
Time frame: Up to Day 365
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Proportion of patients (%) with SADRs
Time frame: Up to Day 365
Proportion of patients (%) with ADRs of severity grade ≥ 3
Proportion of patients (%) with ADRs of severity grade ≥ 3
Time frame: Up to Day 365
Proportion of patients (%) who required discontinuation of treatment due to development of ADRs
Proportion of patients (%) who required discontinuation of treatment due to development of ADRs
Time frame: Up to Day 365
Proportion of patients (%) who developed anti-drug antibodies (ADA) to cetuximab
Proportion of patients (%) who developed anti-drug antibodies (ADA) to cetuximab
Time frame: Pre-dose in Period 1 on Days 1, 15, 29, 57, and 85, and 28 ± 3 days post-last infusion; pre-dose in Period 2 on Days 6, 12, 18, 24, 30, and 36
Proportion of patients (%) who developed neutralizing antibodies (NAb) to cetuximab
Proportion of patients (%) who developed neutralizing antibodies (NAb) to cetuximab
Time frame: Pre-dose in Period 1 on Days 1, 15, 29, 57, and 85, and 28 ± 3 days post-last infusion; pre-dose in Period 2 on Days 6, 12, 18, 24, 30, and 36
Area under the pharmacokinetic curve "concentration-time" (AUC(0-∞)) of cetuximab
Area under the pharmacokinetic curve "concentration-time" of cetuximab after the first administration to infinity (AUC(0-∞))
Time frame: Pre-dose on Day 1 (first administration) and 1, 2, 3, 4, 6, 12, 24, 48, 96, 168 hours post-dose
Time to reach the maximum concentration of cetuximab in the blood serum after the first administration (Tmax)
Time to reach the maximum concentration of cetuximab in the blood serum after the first administration (Tmax)
Time frame: Pre-dose on Day 1 (first administration) and 1, 2, 3, 4, 6, 12, 24, 48, 96, 168 hours post-dose
Elimination half-life of cetuximab after the first administration (T1/2)
Elimination half-life of cetuximab after the first administration (T1/2)
Time frame: Pre-dose on Day 1 (first administration) and 1, 2, 3, 4, 6, 12, 24, 48, 96, 168 hours post-dose
Volume of distribution of cetuximab after the first administration (Vd)
Volume of distribution of cetuximab after the first administration (Vd)
Time frame: Pre-dose on Day 1 (first administration) and 1, 2, 3, 4, 6, 12, 24, 48, 96, 168 hours post-dose
Elimination rate constant of cetuximab after the first administration (Kel)
Elimination rate constant of cetuximab after the first administration (Kel)
Time frame: Pre-dose on Day 1 (first administration) and 1, 2, 3, 4, 6, 12, 24, 48, 96, 168 hours post-dose
Area under the pharmacokinetic curve "concentration-time" of cetuximab to infinity at steady state (AUC(0-∞) ss)
Area under the pharmacokinetic curve "concentration-time" of cetuximab to infinity at steady state (AUC(0-∞) ss)
Time frame: Pre-dose on Day 22 (fourth infusion) and 1, 2, 3, 4, 6, 12, 24, 168 hours post-dose
Time to reach the maximum concentration of cetuximab at steady state (Tmax ss)
Time to reach the maximum concentration of cetuximab at steady state (Tmax ss)
Time frame: Pre-dose on Day 22 (fourth infusion) and 1, 2, 3, 4, 6, 12, 24, 168 hours post-dose
Elimination half-life of cetuximab at steady state (T1/2 ss)
Elimination half-life of cetuximab at steady state (T1/2 ss)
Time frame: Pre-dose on Day 22 (fourth infusion) and 1, 2, 3, 4, 6, 12, 24, 168 hours post-dose
Volume of distribution of cetuximab at steady state (Vd, ss)
Volume of distribution of cetuximab at steady state (Vd, ss)
Time frame: Pre-dose on Day 22 (fourth infusion) and 1, 2, 3, 4, 6, 12, 24, 168 hours post-dose
Residual concentration of cetuximab at repeated administration (Cthrough)
Residual concentration of cetuximab at repeated administration (Cthrough)
Time frame: Visits 18 (Day 120)
Objective response rate (%) (ORR)
Objective response rate (%) (ORR) for a period of up to 18 weeks of therapy inclusive The objective response rate (ORR) is defined as the percentage of patients in each treatment group who achieve a complete or partial tumor response to therapy according to RECIST 1.1 criteria: * Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \< 10 mm * Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks compared with the baseline sum at screening
Time frame: At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120)
Objective response rate (%) (ORR)
Objective response rate (%) (ORR) for a period of up to 6 months of therapy inclusive The objective response rate (ORR) is defined as the percentage of patients in each treatment group who achieve a complete or partial tumor response to therapy according to RECIST 1.1 criteria: * Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \< 10 mm * Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks compared with the baseline sum at screening
Time frame: Up to Week 9 (Visit 9) in Period 2
Disease control rate (DCR) (%)
Disease control rate (DCR) (%) for a period of up to 18 weeks of therapy inclusive The disease control rate is defined as the percentage of patients in a given treatment group who achieve a complete response, partial response, or stable disease during therapy, in accordance with RECIST 1.1 criteria: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements * Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study
Time frame: At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120)
Disease control rate (DCR) (%)
Disease control rate (DCR) (%) for a period of up to 6 months of therapy inclusive The disease control rate is defined as the percentage of patients in a given treatment group who achieve a complete response, partial response, or stable disease during therapy, in accordance with RECIST 1.1 criteria: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements * Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study
Time frame: Up to Week 9 (Visit 9) in Period 2
Disease control rate (DCR) (%) (non-comparative evaluation in the RPH-002 group)
Disease control (DCR) (%) within a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-002 group) The disease control rate is defined as the percentage of patients in a given treatment group who achieve a complete response, partial response, or stable disease during therapy, in accordance with RECIST 1.1 criteria: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements * Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study
Time frame: At Visits 6, 12, and 18 in Period 1 (Days 36, 78, and 120) and Visits 6, 12, 18, 24, 30, and 36 in Period 2 (Weeks 6-36)
Objective response rate (%) (ORR) (non-comparative evaluation in the RPH-002 group)
Objective response rate (%) (ORR) for a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-002 group) The objective response rate (ORR) is defined as the percentage of patients in each treatment group who achieve a complete or partial tumor response to therapy according to RECIST 1.1 criteria: * Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \< 10 mm * Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks compared with the baseline sum at screening
Time frame: At Visits 6, 12, and 18 in Period 1 (Days 36, 78, and 120) and Visits 6, 12, 18, 24, 30, and 36 in Period 2 (Weeks 6-36)
Progression-free survival (PFS)
Progression-free survival (PFS) expressed as the rate (%) of 6-month PFS PFS is defined as the time from randomization to disease progression according to RECIST 1.1 (an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions), clinical progression, or death from any cause
Time frame: Up to Week 9 (Visit 9) in Period 2
Progression-free survival (PFS) (non-comparative evaluation in the RPH-002 group)
Progression-free survival (PFS) expressed as the rate (%) of 1-year PFS (non-comparative evaluation in the RPH-002 group) PFS is defined as the time from randomization to disease progression according to RECIST 1.1 (an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions), clinical progression, or death from any cause
Time frame: Up to Day 365
Overall survival (OS) (non-comparative evaluation in the RPH-002 group)
Overall survival (OS) expressed as median OS for a period of up to 1 year of therapy (non-comparative evaluation in the RPH-002 group)
Time frame: Up to Day 365
Ran from Jun 2020 to primary completion in Jul 2024, 49 months.
Of 154 industry-sponsored phase 1 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 72. This study's 49 months is close to that.
Counting every sponsor, half of 267 studies reached it within 49 months; a quarter within 33 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cetuximab
Squamous Cell Carcinoma of Head and Neck →