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A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With a PD-1 Inhibitor

Cancer Clinical Trial

Official title:
A Phase 1-2 Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With a PD-1 Inhibitor in Subjects With Advanced Malignancies

Clinical Trial Summary

This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805 administered as a monotherapy and in combination with a PD-1 inhibitor in subjects with advanced solid tumors.

Clinical Trial Description

This Phase 1-2 study is designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805, a fully human IgG1 antibody that binds specifically to CD163, in subjects with advanced solid tumors. The study consists of four parts: - Part A: a dose-escalation phase to determine the maximum-tolerated dose (MTD) or maximum achievable dose and the recommended phase 2 dose (RP2D) of OR2805 in a maximum of approximately 20 subjects. - Part B: a monotherapy expansion phase of up to approximately 40 subjects in each of 4 select tumor types at the RP2D to determine preliminary anti-tumor activity and further characterize safety. - Part C: a mini-dose-escalation at 2 doses of OR2805 in combination with a PD-1 inhibitor followed by a combination expansion cohort of up to approximately 40 subjects in each of 2 tumor types to determine the safety and preliminary anti-tumor activity of OR2805 in combination with a PD-1 inhibitor. - Part D: a biology cohort of up to approximately 20 subjects at the RP2D to determine mechanism of action and potential predictors of response and pharmacodynamics in subjects not eligible for either Part B or C. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05094804
Study type Interventional
Source OncoResponse, Inc.
Contact Kate Harrop
Phone 425-420-0749
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date September 9, 2021
Completion date August 15, 2024
View Details
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