Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Cemiplimab

Immunoglobulins

Antineoplastic Agents, Immunological

Escalating repeated doses of OR502 by IV administration as monotherapy or in combination with cemiplimab in subjects with advanced solid tumors. OR502 will be administered once every 3 weeks (Q3W).

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

OR502 administered IV at 2 different dose levels identified in Part A as monotherapy or in combination with cemiplimab in subjects with platinum-resistant ovarian cancer and cutaneous squamous cell carcinoma.

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

IgG1 monoclonal antibody that binds specifically to the LILRB2 protein.

OR502

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

Kate Harrop

Andrae Vandross, MD

Shiraj Sen, MD

David Sommerhalder, MD

Mohamad A Salkeni, 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 OR502 administered as a monotherapy and in combination with cemiplimab 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 OR502, a fully human IgG1 antibody that binds specifically to LILRB2, in subjects with advanced solid tumors. The study consists of two parts:

Part A: a dose-escalation phase to determine the maximum-tolerated dose (MTD), maximum achievable dose, or optimal dose of OR502 for further evaluation as monotherapy and in combination with cemiplimab in a maximum of approximately 48 subjects.

Part B: an expansion phase in subjects with advanced solid tumors treated with OR502 at 2 separate doses as monotherapy followed by combination with cemiplimab, and in subjects with previously treated platinum-resistant ovarian cancer (PROC) or cutaneous squamous cell carcinoma (CSCC) treated with OR502 at 2 separate doses in combination with cemiplimab. Up to approximately 20 subjects will be treated in each arm of the 3 Part B cohorts to further characterize safety, help determine the recommended Phase 2 dose (RP2D) for further development and determine preliminary anti-tumor activity. Up to approximately 120 subjects total will be treated in Part B.

A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents

A Phase 1/2 Study of OR502 Alone and in Combination With Other Anti-cancer 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 graded by CTCAE v 5.0 as aggregated descriptive findings.

Assessment of changes in vital sign measurements (heart rate, pulse oximetry and blood pressure) as aggregated descriptive findings.

Determination of the recommended dose of OR502 for further development.

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.

Spots Global Cancer Trial Database for or502

Every month we try and update this database with for or502 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 or502

Every month we try and update this database with for or502 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 or502 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.