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COMPLETED
NCT04544748
PHASE1

A Phase 1 Study of GNR-051 in Subjects With Advanced Malignancies

Sponsor: AO GENERIUM

View on ClinicalTrials.gov

Summary

It is a Phase 1 Multicenter Open-Label Multi-Cohort Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GNR-051 in Subjects with Advanced Solid Malignancies.

Official title: A Multicenter Open-Label Multi-Cohort Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GNR-051 (GENERIUM JSC, Russia) in Subjects With Solid Advanced Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2020-07-22

Completion Date

2023-12-25

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

GNR-051

Anti-PD1 monoclonal antibody

Locations (12)

SAHI "Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan"

Kazan', Russia

FSBI "N.N. Blokhin National Medical Research Center of Oncology"of the Ministry of Health of the Russian Federation

Moscow, Russia

FSBI "Russian Scientific Center of Roentgenoradiology" of the Ministry of Health of the Russian Federation

Moscow, Russia

FSAEI HE "I.M. Sechenov First Moscow State Medical University" of the Ministry of Health of Russian Federation

Moscow, Russia

JSC "MEDSI" Group of Companies"

Moscow, Russia

FSII "Treatment and Rehabilitation Center" of the Ministry of Health of the Russian Federation

Moscow, Russia

FSBI "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Healthcare of the Russian Federation

Moscow, Russia

SBHI "Leningrad Regional Clinical Oncology Dispensary"

Saint Petersburg, Russia

JSC "Modern Medical Technologies"

Saint Petersburg, Russia

FSAEI HE "I.P. Pavlov First Saint Petersburg State Medical University" of the Ministry of Health of the Russian Federation

Saint Petersburg, Russia

SBHI "St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

Saint Petersburg, Russia

LLC "Tentanda Via"

Saint Petersburg, Russia