Overview

Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms

Status:
ACTIVE_NOT_RECRUITING

Trial end date:
2025-07-01

Target enrollment:

Participant gender:

Summary

The goal of this double-blind, randomized study is to establish the equivalence of pharmacokinetic properties, as well as the comparability of safety, immunogenicity and pharmacodynamics of the drug RPH-075 (international nonproprietary name (INN) is pembrolizumab) in comparison with the drug Keytruda® (INN is pembrolizumab) after a single intravenous injection to patients with malignant neoplasms as a first or second line therapy in a monotherapy regimen. The main main tasks are: * To evaluate and compare the pharmacokinetic properties of RPH-075 and Keytruda® after a single intravenous administration of pembrolizumab to patients with malignant neoplasms; * To evaluate the safety profile of the drug RPH-075 in comparison with the drug Keytruda® when used in patients with malignant neoplasms when used as a 1st or 2nd line therapy in a monotherapy regimen. This study will also include a comparative assessment of immunogenicity, pharmacodynamic parameters and a pilot evaluation of RPH-075 efficacy.

Phase:

PHASE1

Details

Lead Sponsor:

R-Pharm

Collaborators:

Data Management 365
Exacte Labs LLC
Federal State Budgetary Institution "NMIC of Hematology" of the Ministry of Health of the Russian Federation
Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor

Treatments:

pembrolizumab