Spots Global Cancer Trial Database for A Phase 1 Study of GNR-051 in Subjects With Advanced Malignancies
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Trial Identification
Brief Title: A Phase 1 Study of GNR-051 in Subjects With Advanced 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
Study ID: NCT04544748
Interventions
Study Description
Brief 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.
Detailed Description: GNR-051 is a monoclonal antibody, targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. The anti-PD-1 antibody, preventing the binding of the PD-1 receptor with the ligands PD-L1 and PD-L2, reactivates the pool of tumor-specific cytotoxic T-lymphocytes in the tumor microenvironment and, thus, reactivates the antitumor immunity. GNR-051 is able to block the signaling molecule PD-1, which suppresses the antitumor immune response, for the treatment of cancer.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
SAHI "Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan", Kazan, , Russian Federation
FSBI "N.N. Blokhin National Medical Research Center of Oncology"of the Ministry of Health of the Russian Federation, Moscow, , Russian Federation
FSBI "Russian Scientific Center of Roentgenoradiology" of the Ministry of Health of the Russian Federation, Moscow, , Russian Federation
FSAEI HE "I.M. Sechenov First Moscow State Medical University" of the Ministry of Health of Russian Federation, Moscow, , Russian Federation
JSC "MEDSI" Group of Companies", Moscow, , Russian Federation
FSII "Treatment and Rehabilitation Center" of the Ministry of Health of the Russian Federation, Moscow, , Russian Federation
FSBI "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Healthcare of the Russian Federation, Moscow, , Russian Federation
SBHI "Leningrad Regional Clinical Oncology Dispensary", Saint Petersburg, , Russian Federation
JSC "Modern Medical Technologies", Saint Petersburg, , Russian Federation
FSAEI HE "I.P. Pavlov First Saint Petersburg State Medical University" of the Ministry of Health of the Russian Federation, Saint Petersburg, , Russian Federation
SBHI "St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological), Saint Petersburg, , Russian Federation
LLC "Tentanda Via", Saint Petersburg, , Russian Federation
Contact Details
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