NCT05094804

A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents

A Phase 1-2 Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents in Subjects With Advanced Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: OncoResponse, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 anti-cancer agents in subjects with advanced solid tumors.

Detailed 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 three parts: * Part A: a dose-escalation phase to determine the maximum-tolerated dose (MTD), maximum achievable dose, or recommended phase 2 dose (RP2D) of OR2805 given alone or in combination with cemiplimab or docetaxel in a maximum of approximately 54 subjects. * Part B: an expansion phase in subjects with melanoma or non-small cell lung cancer (NSCLC) treated with OR2805 as monotherapy at the RP2D or OR2805 in combination with cemiplimab or docetaxel. Up to approximately 20 subjects will be treated in each arm of the 3 Part B cohorts to further characterize safety and determine the preliminary anti-tumor activity. * Part C: a biology cohort of up to approximately 40 subjects at the RP2D to determine the mechanism of action and potential predictors of response and pharmacodynamic markers in subjects with liposarcoma, leiomyocarcoma, or squamous cell carcinoma of the head and neck (SCCHN) or are not otherwise eligible for Part B. All subjects in Part C will undergo biopsies.

Conditions

• Cancer
• Tumor, Solid
• Malignant Neoplasm
• Metastatic Cancer
• Advanced Solid Tumor
• Non Small Cell Lung Cancer
• Melanoma
• Head and Neck Squamous Cell Carcinoma
• Leiomyosarcoma
• Liposarcoma

Interventions

Type	Name	Description
DRUG	OR2805	IgG1 monoclonal antibody that binds specifically to the CD163 protein.
DRUG	Cemiplimab	IgG4 mAb that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.
DRUG	Docetaxel	An antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.

Timeline

• Start date: 2021-09-09
• Primary completion: 2024-04-15
• Completion: 2024-08-15
• First posted: 2021-10-26
• Last updated: 2023-11-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study