NCT07435324

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

An International, Multicenter, Open-label, Randomized, Comparative Study of the Efficacy and Safety of RPH-002 and Erbitux® in Patients With Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study is a international, multicenter, open-label, randomized, parallel-group Phase III study The study will include the following periods: 1. Screening Period 1 Includes Days -14 to -1 (prior to the first administration of the investigational product/comparator) 2. Main Period (Period 1) The main study period includes Days 1-126 The Main Period begins with administration of cetuximab (RPH-002 or Erbitux®) and chemotherapy on Day 1 of Cycle 1. Chemotherapy continues for up to 6 cycles, each lasting 3 weeks (21 days). Chemotherapy agents are administered no earlier than 1 hour after completion of cetuximab infusion. Cetuximab is administered weekly for up to 18 doses In Period 1, tumor response is assessed every 6 weeks 3. Screening Period 2 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 are evaluated to determine eligibility for continuation of therapy in the Maintenance Therapy Period 4. Maintenance Therapy Period (Period 2) Includes Days 127-386 In the Maintenance Therapy Period, patients with a tumor response or stable disease at Week 18 of Period 1 are included in the study. Tumor response is assessed 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 * Progressive Disease (PD) - at least a 20% increase 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 * 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 During the Maintenance Therapy Period, patients receive monotherapy with cetuximab at 250 mg/m² once weekly. The maximum number of administrations of cetuximab during this period is 36 Therapy continues until the earliest of the following: * up to 54 weeks from the start of study treatment * disease progression (per RECIST 1.1 or clinical progression) * unacceptable toxicity Radiologically confirmed progression according to RECIST 1.1 criteria is defined as 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 In Period 2, tumor response is assessed every 6 weeks 5. Follow-up Period The Follow-Up Period assesses the safety of study therapy in all patients who complete Period 1 and do not enter Period 2, as well as in patients who complete therapy in Period 2. The period lasts 28 ± 3 days after the last study drug administration (if therapy completes as planned at 54 weeks) or until death, loss to follow-up, or Day 365, whichever occurs first. A single follow-up visit is conducted 28 ± 3 days after the last study drug administration

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	RPH-002	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
DRUG	Erbitux®	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
DRUG	Cisplatin	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
DRUG	Docetaxel	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

Timeline

• Start date: 2024-08-08
• Primary completion: 2025-09-29
• Completion: 2026-06-21
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

34 sites across 2 countries: Russia, Uzbekistan