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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

December 11, 2023

Study Completion Date

July 31, 2025

Conditions
Skin MelanomaSquamous Non-small-cell Lung CancerHead and Neck Squamous Cell Carcinoma
Interventions
DRUG

RPH-075

"100 mg/4 mL (25 mg/mL) concentrate for solution for infusions in a single-dose vial~The required volume (8 ml) of the Drug concentrate solution should be withdrawn from the vials and transferred into an intravenous bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection. (The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.)"

DRUG

Keytruda®

"100 mg/4 mL (25 mg/mL) concentrate for solution for infusions in a single-dose vial~The required volume (8 ml) of the Drug concentrate solution should be withdrawn from the vials and transferred into an intravenous bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection. (The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.)"

Trial Locations (23)

105005

"State Budgetary Healthcare Institution of the city of Moscow City Clinical Oncological Hospital No. 1 of the Department of Health of the City of Moscow", Moscow

111123

"State Budgetary Institution of Healthcare of the city of Moscow Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow", Moscow

115478

"Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation", Moscow

119435

"Federal State Budgetary Scientific Institution Russian Scientific Center of Surgery named after Academician B.V. Petrovsky", Moscow

119991

Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow

123056

Medsi Group of Companies JSC, Moscow

127521

"Research lab LLC", Moscow

143423

"State Budgetary Healthcare Institution of the city of Moscow Moscow City Oncological Hospital No. 62 of the Department of Health of the City of Moscow", Istra

153040

"Regional budgetary healthcare institution Ivanovo Regional Oncological Dispensary", Ivanovo

163045

"State Budgetary Healthcare Institution of the Arkhangelsk region Arkhangelsk Clinical Oncological Dispensary", Arkhangelsk

188300

State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital, Saint Petersburg

195271

"Private healthcare institution Clinical Hospital Russian Railways-Medicine of the city of St. Petersburg", Saint Petersburg

196006

"Av Medical Group LLC", Saint Petersburg

197022

"St. Petersburg State Budgetary Healthcare Institution City Clinical Oncological Dispensary", Saint Petersburg

197758

"Federal State Budgetary Institution N.N. Petrov National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation", Saint Petersburg

357500

"New Clinic LLC", Pyatigorsk

428020

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

443031

"State Budgetary Healthcare Institution Samara Regional Clinical Oncological Dispensary", Samara

450054

State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Bashkortostan, Ufa

614066

"State Budgetary Healthcare Institution of the Perm Territory Perm Regional Oncological Dispensary", Perm

625041

"The State Autonomous healthcare Institution of the Tyumen region Multidisciplinary clinical Medical Center Medical City", Tyumen

650036

"State Budgetary healthcare Institution Kuzbass Clinical Oncological Dispensary named after M.S. Rappoport", Kemerovo

656045

"Regional State Budgetary Healthcare Institution Altai Regional Oncological Dispensary", Barnaul

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Data Management 365

INDUSTRY

collaborator

Exacte Labs LLC

INDUSTRY

collaborator

"Federal State Budgetary Institution NMIC of Hematology of the Ministry of Health of the Russian Federation"

UNKNOWN

collaborator

Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor

UNKNOWN

lead

R-Pharm

INDUSTRY