NCT07435311

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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: 1. Screening Period 1 (up to 15 days) Includes Days -14 to 0 (prior to the first administration of the investigational product/comparator) 2. 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 3. 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 4. 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 5. 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

Interventions

Type	Name	Description
DRUG	RPH-002	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
DRUG	Erbitux®	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
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: 2020-06-15
• Primary completion: 2024-07-17
• Completion: 2024-07-17
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

18 sites across 1 country: Russia