A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma

NCT07435324 | Active Not Recruiting Phase 3

• 1 other identifier: CL01002356
• Study Type: interventional
• Target: 161
• Locations: 2 countries
• Sites: 34

Brief Summary

The primary objective of the study is to evaluate the comparability of efficacy, safety, and immunogenicity of RPH-002 and Erbitux® when administered in combination with docetaxel and cisplatin as first-line therapy in patients with advanced head and neck squamous cell carcinoma

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Squamous Cell Carcinoma; RPH-002

Outcome Measures

Primary Outcomes (1)

• 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 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

  At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120)

Secondary Outcomes (10)

• Disease Control Rate (%) (DCR; CR + PR + SD)

  At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120)

• Proportion of patients (%) with adverse drug reactions (ADRs) of any severity

  Up to Day 365

• Proportion of patients (%) with adverse events (AEs) of any severity

  Up to Day 365

• Proportion of patients (%) with AEs of severity grade ≥ 3

  Up to Day 365

• Proportion of patients (%) with ADRs of severity grade ≥ 3

  Up to Day 365

Other Outcomes (7)

• Objective response rate (%) (ORR)

  Up to Week 9 (Visit 9) in Period 2

• Objective response rate (%) (ORR) (non-comparative evaluation in the RPH-002 group)

  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)

• Disease Control Rate (%) (DCR; CR + PR + SD)

  Up to Week 9 (Visit 9) in Period 2

Study Arms (2)

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

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 8 weeks), or until disease progression or unacceptable toxicity Patients who received therapy with Erbitux® during the Main Period will be switched to therapy with RPH-002 starting from Week 9 of the Maintenance Period

Drug: Erbitux®; Drug: Cisplatin; Drug: Docetaxel

Interventions

RPH-002 DRUG

RPH-002: solution for infusion, 100 mg/20 mL (5 mg/mL) per vial 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: Arcetux®, L01002, cetuximab

RPH-002 + docetaxel + cisplatin

Erbitux® DRUG

Erbitux®: solution for infusion, 5 mg/mL; vials of 10, 20, 50, and 100 mL containing 50, 100, 250, and 500 mg of the drug, respectively 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

Erbitux® + docetaxel + cisplatin

Cisplatin DRUG

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

Erbitux® + docetaxel + cisplatin; RPH-002 + docetaxel + cisplatin

Docetaxel DRUG

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

Erbitux® + docetaxel + cisplatin; RPH-002 + docetaxel + cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (34)

State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncological Dispensary"

Arkhangelsk, 163045, Russia

Location

State Budgetary Healthcare Institution "Regional Oncological Dispensary"

Irkutsk, 664035, Russia

Location

State Budgetary Healthcare Institution of Moscow "Moscow City Oncological Hospital No. 62, Department of Health of Moscow"

Istra, 143515, Russia

Location

Regional Budgetary Healthcare Institution "Ivanovo Regional Oncological Dispensary"

Ivanovo, 153040, Russia

Location

Budgetary Healthcare Institution of the Udmurt Republic "Sergey Grigoryevich Primushko Republican Clinical Oncological Dispensary" of the Ministry of Health of the Udmurt Republic

Izhevsk, 571207, Russia

Location

State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"

Kaluga, 248007, Russia

Location

State Autonomous Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"

Kazan', 420029, Russia

Location

State Budgetary Healthcare Institution "Kuzbass Clinical Oncology Dispensary named after M.S. Rappoport" (SBHI "KCOD")

Kemerovo, 650036, Russia

Location

Kirov Regional State Clinical Budgetary Healthcare Institution "Center of Oncology and Medical Radiology"

Kirov, 610045, Russia

Location

State Budgetary Healthcare Institution "Clinical Oncological Dispensary No. 1" of the Ministry of Health of Krasnodar Krai

Krasnodar, 350040, Russia

Location

State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"

Kuz'molovskiy, 191104, Russia

Location

Federal State Budgetary Institution "N.N. Burdenko Main Military Clinical Hospital" of the Ministry of Defense of the Russian Federation

Moscow, 105094, Russia

Location

State Budgetary Healthcare Institution of Moscow "A.S. Loginov Moscow Clinical Scientific and Practical Center" of the Moscow Department of Health

Moscow, 111123, Russia

Location

Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation (Sechenov University)

Moscow, 119435, Russia

Location

Branch of the Limited Liability Company "Hadassah Medical Ltd." (LLC Branch "Hadassah Medical")

Moscow, 121205, Russia

Location

Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian Federation

Moscow, 125367, Russia

Location

State Budgetary Healthcare Institution of Moscow "City Clinical Hospital named after S.S. Yudin, Department of Health of Moscow"

Moscow, 129090, Russia

Location

Joint-Stock Company "Medsi Group of Companies"

Moscow, 143442, Russia

Location

State Autonomous Healthcare Institution of the Nizhny Novgorod Region "Research Institute of Clinical Oncology 'Nizhny Novgorod Regional Clinical Oncology Dispensary'"

Nizhny Novgorod, 603081, Russia

Location

Limited Liability Company Medical and Sanitary Unit "Clinician-Pretor Clinic"

Novosibirsk, 630091, Russia

Location

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, Russia

Location

Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation, Branch: P.A. Herzen Moscow Research Oncology Institute

Obninsk, 249036, Russia

Location

Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"

Omsk, 644013, Russia

Location

Private Medical Institution "Euromedservice"

Pushkin, 196603, Russia

Location

State Budgetary Healthcare Institution of Stavropol Krai "Pyatigorsk Interdistrict Oncology Dispensary"

Pyatigorsk, Russia

Location

Federal State Budgetary Institution "National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation

Rostov-on-Don, 344037, Russia

Location

Private Healthcare Institution "RZD-Medicine Clinical Hospital" of Saint Petersburg

Saint Petersburg, 195271, Russia

Location

Limited Liability Company "EuroCityClinic"

Saint Petersburg, 197022, Russia

Location

Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"

Saint Petersburg, 197022, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation

Tomsk, 634028, Russia

Location

State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary" of the Ministry of Health of the Republic of Bashkortostan

Ufa, 450054, Russia

Location

State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncological Hospital"

Yaroslavl, 150054, Russia

Location

State Autonomous Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Dispensary"

Yekaterinburg, 620036, Russia

Location

Republican Specialized Scientific and Practical Medical Center of Oncology and Radiology, Tashkent Regional Branch

Tashkent, 100128, Uzbekistan

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab; Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: August 8, 2024
• Primary Completion: September 29, 2025
• Study Completion (Estimated): June 21, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

RU (33); UZ (1)