Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Melanoma

Liposarcoma

Leiomyosarcoma

Squamous Cell Carcinoma of Head and Neck

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Head and Neck Neoplasms

Neoplasms, Connective and Soft Tissue

Sarcoma

Neoplasms, Adipose Tissue

Soft Tissue Sarcoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Docetaxel

Cemiplimab

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Escalating repeated doses of OR2805 by IV administration as monotherapy or in combination with cemiplimab or docetaxel in subjects with advanced solid tumors. OR2805 will be administered once every 3 weeks (Q3W) or once-weekly (QW) for 3 weeks as an IV infusion over 30 minutes.

Cemiplimab will be administered as an IV infusion at a dose of 350 mg.

Docetaxel will be administered as an IV infusion at a dose of 75 mg/m2.

OR2805 administered IV at the RP2D and dosing regimen identified in Part A as monotherapy or in combination with cemiplimab or docetaxel in subjects with NSCLC and melanoma.

Cemiplimab will be administered as an IV infusion at a dose of 350 mg.

Docetaxel will be administered as an IV infusion at a dose of 75 mg/m2.

OR2805 administered IV at the RP2D and dosing regimen identified in Part A as monotherapy to determine the mechanism of action and potential predictors of response and pharmacodynamic markers in subjects with liposarcoma, leiomyosarcoma, or SCCHN or are not otherwise eligible for Cohort B.

IgG1 monoclonal antibody that binds specifically to the CD163 protein.

OR2805

IgG4 mAb that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.

An antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.

Kate Harrop

Michael S Gordon, MD

Andrae Vandross, MD

Anthony W Tolcer, MD

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.

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.

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

The incidence of DLTs during the DLT assessment period.

The nature, frequency, and severity of adverse events and serious adverse events, treatment discontinuations due to toxicity, and clinical laboratory abnormalities; recording of infusion-related reactions; physical examination and ECG findings; vital sign measurements; ECOG performance status scores; markers of inflammation and immunogenicity.

Determination of the MTD or maximum achievable dose, and the RP2D.

Area under the plasma concentration versus time curve (AUC).

The percentage of subjects with a complete response, partial response, or stable disease for at least 2 consecutive tumor assessments.

Time from the date of initiation of study therapy to the date measurement criteria are first met for PD or death from any cause, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	NCT05094804	Cancer Tumor, Solid Malignant Neopl... Metastatic Canc... Advanced Solid ... Non Small Cell ... Melanoma Head and Neck S... Leiomyosarcoma Liposarcoma	OR2805 Cemiplimab Docetaxel	18 Years -	OncoResponse, Inc.
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	NCT05094804	Cancer Tumor, Solid Malignant Neopl... Metastatic Canc... Advanced Solid ... Non Small Cell ... Melanoma Head and Neck S... Leiomyosarcoma Liposarcoma	OR2805 Cemiplimab Docetaxel	18 Years -	OncoResponse, Inc.

Spots Global Cancer Trial Database for or2805

Every month we try and update this database with for or2805 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for or2805

Every month we try and update this database with for or2805 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for or2805 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.