NCT04544748

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	GNR-051	Anti-PD1 monoclonal antibody

Timeline

• Start date: 2020-07-22
• Primary completion: 2022-11-07
• Completion: 2025-01-01
• First posted: 2020-09-10
• Last updated: 2024-03-06

Locations

12 sites across 1 country: Russia