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

NCT07435311 | Completed Phase 1

• 1 other identifier: CL01002062
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 18

Brief 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 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

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Squamous Cell Carcinoma; RPH-002

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to Day 365

Secondary Outcomes (12)

• Maximum serum concentration of cetuximab after the first administration (Cmax)

  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)

  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)

  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)

  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

  Up to Day 365

Other Outcomes (19)

• Area under the pharmacokinetic curve "concentration-time" (AUC(0-∞)) of cetuximab

  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)

  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)

  Pre-dose on Day 1 (first administration) and 1, 2, 3, 4, 6, 12, 24, 48, 96, 168 hours post-dose

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 36 weeks), or until disease progression or unacceptable toxicity

Drug: Erbitux®; Drug: cisplatin; Drug: docetaxel

Interventions

RPH-002 DRUG

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

RPH-002 + docetaxel + cisplatin

Erbitux® DRUG

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

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
• 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
• 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

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 (18)

Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"

Barnaul, 656045, Russia

Location

Autonomous Institution of the Chuvash Republic "Republican Clinical Oncological Dispensary" of the Ministry of Health of the Chuvash Republic

Cheboksary, 428020, 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

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

Kaluga, 248007, Russia

Location

State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"

Kuz'molovskiy, 191104, Russia

Location

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, Russia

Location

Limited Liability Company "COMPAS-LA"

Moscow, 119602, 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 Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Regional Clinical Oncological Dispensary"

Novosibirsk, 630108, 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

Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"

Omsk, 644013, Russia

Location

Private Medical Institution "Euromedservice"

Pushkin, 196603, Russia

Location

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

Saint Petersburg, 197022, 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

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 1
• 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: June 15, 2020
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

RU (18)