Head and Neck Squamous Cell CarcinomaPhase 1NCT07435311
A Phase I Comparative Study of Pharmacokinetics, Safety, and Efficacy of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
A Phase 1 study testing RPH-002, Erbitux® and cisplatin in people with Head and Neck Squamous Cell Carcinoma, run by R-Pharm at 18 sites in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- RPH-002, Erbitux® and cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 18 sitesRussia
- Study dates
- 15 Jun 2020to 17 Jul 2024
- 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
- Main Period (Period 1)
- A voluntarily signed and dated Informed Consent form (ICF) of the patient
- Histologically confirmed squamous cell carcinoma of the head and neck
- Body mass index (BMI) between 18 and 30 kg/m^2, inclusive
- Documented unresectable locoregional recurrence or distant metastases, or progression after prior chemoradiotherapy or combination therapy completed >3 months before screening, not amenable to local treatment (except cases with high risk of tumor lysis or bleeding), or newly diagnosed metastatic disease not previously treated with systemic therapy. Study treatment is first-line therapy
- At least one measurable lesion per RECIST 1.1
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- Karnofsky performance status ≥70%
- Screening laboratory values within the following limits (per local lab normal ranges):
- Hemoglobin ≥90 g/L
- Leukocytes ≥3.0 × 10^9/L
- Neutrophils ≥1.5 × 10^9/L
- Platelets ≥100 × 10^9/L
- Total bilirubin ≤2 × Upper Limit of Normal (ULN)
- Aspartate aminotransferase (AST) ≤3 × ULN
- Alanine aminotransferase (ALT) ≤3 × ULN
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min
- Men and women of childbearing potential, and women within 2 years of menopause, must agree to use reliable contraception from informed consent through at least 6 months after study treatment; women of childbearing potential must have a negative urine pregnancy test. Women with no reproductive potential (≥2 years post-menopause or surgically sterile) are exempt
- Ability and willingness to comply with study protocol and procedures for the planned duration of participation
- Ability to undergo required pharmacokinetic sample collection, as judged by the investigator
- Maintenance Therapy Period (Period 2)
- Documented tumor response or disease stabilization per RECIST 1.1 by computed tomography (CT) or magnetic resonance imaging (MRI) at Week 18 of the Main Period
- Ability and willingness to provide written informed consent for participation in Period 2
- Karnofsky performance status ≥ 70%
- Laboratory values within the following limits (per local lab normal ranges):
- Hemoglobin ≥ 90 g/L
- Leukocytes ≥ 3.0 × 10^9/L
- Neutrophils ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
- Total bilirubin ≤ 2 × ULN (upper limit of normal)
- AST ≤ 3 × ULN
- ALT ≤ 3 × ULN
- eGFR ≥ 60 mL/min
- Men and women of childbearing potential, and women within 2 years of menopause, must agree to use reliable contraception from informed consent through at least 6 months after study treatment; women of childbearing potential must have a negative urine pregnancy test. Women with no reproductive potential (≥2 years post-menopause or surgically sterile) are exempt
Who cannot join
- Main Period (Period 1)
- Prior therapy with cetuximab or other monoclonal antibody-based biologics
- Chemotherapy, radiotherapy, or surgery for head and neck cancer within 3 months before screening
- Any other surgery (except biopsy, implantable venous port placement, or urgent non-cancer surgery) within 3 months before screening
- Nasopharyngeal carcinoma
- Other malignancy within the past 5 years or prior/concurrent squamous cell carcinoma (except cured in situ ductal carcinoma, cervical carcinoma in situ, basal cell or squamous cell skin cancer)
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- Expected survival < 3 months
- Women who are pregnant or breastfeeding, or unwilling to use effective contraception during the study and for at least 6 months after
- Significant cardiovascular disease per investigator, including uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥130 mmHg), coronary artery disease, myocardial infarction within 12 months, high-risk uncontrolled arrhythmias, or uncontrolled heart failure
- Active infection requiring systemic antibiotic therapy
- Ongoing systemic immunotherapy, hormone therapy, or other cancer treatments not specified in the protocol within 6 months prior to screening or during the study
- Known or suspected brain metastases, including parenchymal, leptomeningeal, or dural involvement associated with symptoms
- Positive screening for HBsAg, anti-HCV, anti-HIV1/2 antibodies, or syphilis within 3 months prior to screening
- Conditions preventing compliance with the study protocol per investigator
- Participation in another investigational drug study within 6 months prior to screening
- Unstable medical conditions, including uncontrolled diabetes, psychiatric disorders, or uncontrolled seizures, that could interfere with protocol adherence
- Known hypersensitivity to any component of study therapy or combination chemotherapy drugs
- Excessive alcohol use (>10 standard drinks/week) or history of alcoholism or substance abuse associated with symptoms. One standard drink = 250 mL beer, 125 mL wine, or 30 mL spirits
- Maintenance Therapy Period (Period 2)
- No documented tumor response or disease stabilization per RECIST 1.1 by CT or MRI at Week 18 of the Main Period
- Women who are pregnant or breastfeeding, or unwilling to use effective contraception during the study and for at least 6 months after
- Significant cardiovascular disease per investigator, including uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥130 mmHg), coronary artery disease, myocardial infarction within 12 months, high-risk uncontrolled arrhythmias, or uncontrolled heart failure
- Active infection requiring systemic antibiotics
- Ongoing systemic immunotherapy, hormone therapy, or other cancer treatments not specified in the protocol for Period 2
- Known or suspected brain metastases, including parenchymal, leptomeningeal, or dural involvement associated with symptoms
- Conditions preventing compliance with study procedures per investigator
- Participation in another investigational drug study
- Unstable medical conditions, including uncontrolled diabetes, psychiatric disorders, or uncontrolled seizures, that could interfere with protocol adherence
- Excessive alcohol use (>10 standard drinks/week) or history of alcoholism or substance abuse associated with symptoms. One standard drink = 250 mL beer, 125 mL wine, or 30 mL spirits
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Russia18 sites
Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"
Barnaul, 656045
Autonomous Institution of the Chuvash Republic "Republican Clinical Oncological Dispensary" of the Ministry of Health of the Chuvash Republic
Cheboksary, 428020
State Budgetary Healthcare Institution "Regional Oncological Dispensary"
Irkutsk, 664035
State Budgetary Healthcare Institution of Moscow "Moscow City Oncological Hospital No. 62, Department of Health of Moscow"
Istra, 143515
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncological Dispensary"
Ivanovo, 153040
State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncological Dispensary"
Kaluga, 248007
State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"
Kuz'molovskiy, 191104
Federal State Autonomous Higher Education Institution "First Moscow State Medical University named after I.M. Sechenov" of the Ministry of Health of the Russian Federation (Sechenov University)
Moscow, 119435
Limited Liability Company "COMPAS-LA"
Moscow, 119602
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital named after S.S. Yudin, Department of Health of Moscow"
Moscow, 129090
Joint-Stock Company "Medsi Group of Companies"
Moscow, 143442
State Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Regional Clinical Oncological Dispensary"
Novosibirsk, 630108
Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation, Branch: A.F. Tsyba Medical Radiological Research Center
Obninsk, 249036
Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"
Omsk, 644013
Private Medical Institution "Euromedservice"
Pushkin, 196603
Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
Saint Petersburg, 197022
State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary" of the Ministry of Health of the Republic of Bashkortostan
Ufa, 450054
State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncological Hospital"
Yaroslavl, 150054
About this study
Official title: An Open-label, Randomized, Multicenter Comparative Study of the Pharmacokinetics, Safety, and Efficacy of RPH-002 and Erbitux® in Patients With Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
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
Read the detailed description
This study is a multicenter, open-label, randomized Phase I study
This clinical study includes the following stages:
- Stage 1: Evaluation of the pharmacokinetics of drugs RPH-002 and Erbitux® after the first administration, and evaluation of the safety and immunogenicity of drugs RPH-002 and Erbitux® after four administrations of the study therapy
- Stage 2: Evaluation of pharmacokinetics, safety, immunogenicity, and pilot efficacy of drugs RPH-002 and Erbitux® during up to 18 weeks of therapy
- Stage 3: Evaluation of safety, immunogenicity, and pilot efficacy of RPH-002 and Erbitux® after 6 months of therapy, as well as evaluation of safety, immunogenicity, and pilot efficacy of drug RPH-002 after 1 year of therapy
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:
- Clinical progression as assessed by the investigator
- Radiologically confirmed progression according to RECIST 1.1 criteria: 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
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:
- 54 weeks from the start of study therapy;
- Disease progression (according to RECIST 1.1 or clinical progression);
- Development of unacceptable toxicity 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
- Follow-up Period
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
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and Neck Squamous Cell Carcinoma, RPH-002
- 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.
RPH-002Drug
Also called cetuximab
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
Erbitux®Drug
Also called 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
cisplatinDrug
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
docetaxelDrug
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
| Study group | Role | What they receive |
|---|---|---|
| RPH-002 + docetaxel + cisplatin | Experimental | 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 Receives: Drug: RPH-002; Drug: cisplatin; Drug: docetaxel |
| Erbitux® + docetaxel + cisplatin | Active comparator | 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 Receives: Drug: Erbitux®; Drug: cisplatin; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to Day 365
Secondary outcomes (12)
Maximum serum concentration of cetuximab after the first administration (Cmax)
Maximum serum concentration of cetuximab after the first administration (Cmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Up to Day 365
Proportion of patients (%) with serious adverse events (SAEs)
Proportion of patients (%) with SAEs
Measured: Up to Day 365
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Proportion of patients (%) with SADRs
Measured: Up to Day 365
Proportion of patients (%) with ADRs of severity grade ≥ 3
Proportion of patients (%) with ADRs of severity grade ≥ 3
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Jun 2020
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435311
- Sponsor's protocol ID
- CL01002062
- Status last verified
- Jul 2026
- First submitted
- 20 Feb 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multicenter Comparative Study of the Pharmacokinetics, Safety, and Efficacy of RPH-002 and Erbitux® in Patients With Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07435311
- Acronym / sponsor ID
- CL01002062
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and Neck Squamous Cell Carcinoma, RPH-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is a multicenter, open-label, randomized Phase I study
This clinical study includes the following stages:
- Stage 1: Evaluation of the pharmacokinetics of drugs RPH-002 and Erbitux® after the first administration, and evaluation of the safety and immunogenicity of drugs RPH-002 and Erbitux® after four administrations of the study therapy
- Stage 2: Evaluation of pharmacokinetics, safety, immunogenicity, and pilot efficacy of drugs RPH-002 and Erbitux® during up to 18 weeks of therapy
- Stage 3: Evaluation of safety, immunogenicity, and pilot efficacy of RPH-002 and Erbitux® after 6 months of therapy, as well as evaluation of safety, immunogenicity, and pilot efficacy of drug RPH-002 after 1 year of therapy
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:
- Clinical progression as assessed by the investigator
- Radiologically confirmed progression according to RECIST 1.1 criteria: 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
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:
- 54 weeks from the start of study therapy;
- Disease progression (according to RECIST 1.1 or clinical progression);
- Development of unacceptable toxicity 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
- Follow-up Period
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPH-002 + docetaxel + cisplatin | Experimental | Drug: RPH-002, Drug: cisplatin, Drug: docetaxelPatients 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 |
| Erbitux® + docetaxel + cisplatin | Active comparator | Drug: Erbitux®, Drug: cisplatin, Drug: docetaxelPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Main Period (Period 1)
- A voluntarily signed and dated Informed Consent form (ICF) of the patient
- Histologically confirmed squamous cell carcinoma of the head and neck
- Body mass index (BMI) between 18 and 30 kg/m^2, inclusive
- Documented unresectable locoregional recurrence or distant metastases, or progression after prior chemoradiotherapy or combination therapy completed >3 months before screening, not amenable to local treatment (except cases with high risk of tumor lysis or bleeding), or newly diagnosed metastatic disease not previously treated with systemic therapy. Study treatment is first-line therapy
Key exclusion criteria (29 listed)
- Main Period (Period 1)
- Prior therapy with cetuximab or other monoclonal antibody-based biologics
- Chemotherapy, radiotherapy, or surgery for head and neck cancer within 3 months before screening
- Any other surgery (except biopsy, implantable venous port placement, or urgent non-cancer surgery) within 3 months before screening
- Nasopharyngeal carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPH-002Also: cetuximabRPH-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 | Drug | RPH-002 + docetaxel + cisplatin |
| Erbitux®Also: cetuximabErbitux®: 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 | Drug | Erbitux® + docetaxel + cisplatin |
| cisplatinSolution 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 | Drug | Erbitux® + docetaxel + cisplatin, RPH-002 + docetaxel + cisplatin |
| docetaxelConcentrate 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 | Drug | Erbitux® + docetaxel + cisplatin, RPH-002 + docetaxel + cisplatin |
Primary outcome
Area under the pharmacokinetic curve "concentration-time" (AUC(0-168)) of cetuximab
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 after the first (single dose) administration, truncated at the point before the second administration, i.e. up to 168 hours
Proportion of patients (%) with adverse drug reactions (ADRs) of any severity
Time frame: Up to Day 365
Proportion of patients (%) with adverse drug reactions (ADRs) of any severity
12 secondary outcomes
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)
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)
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)
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
Time frame: Up to Day 365
Proportion of patients (%) with AEs of severity grade ≥ 3
Time frame: Up to Day 365
Proportion of patients (%) with serious adverse events (SAEs)
Time frame: Up to Day 365
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Time frame: Up to Day 365
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
Time frame: Up to Day 365
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Samsonov study director
R-Pharm
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPH-002, Erbitux® and cisplatin in people with Head and Neck Squamous Cell Carcinoma, run by R-Pharm at 18 sites in Russia.
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 33 inclusion and 29 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: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Russia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the pharmacokinetic curve "concentration-time" (AUC(0-168)) of cetuximab (time frame: Pre-dose on Day 1 (first administration) and 1, 2, 3, 4, 6, 12, 24, 48, 96, 168 hours post-dose). 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?
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 Jul 2026.