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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-02-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2024-07-17
Completion
2024-07-17

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07435311 on ClinicalTrials.gov