RecruitingPhase 1Phase 2NCT06090266

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


Sponsor

OncoResponse, Inc.

Enrollment

168 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

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 OR502 administered as a monotherapy and in combination with cemiplimab in subjects with advanced solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing OR502, a new antibody drug that targets a protein called LILRB2 on immune cells, to see if it can help the immune system better fight advanced solid cancers. The drug will be tested alone and in combination with other anti-cancer drugs in people whose cancer has progressed on prior treatments. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of carcinoma, sarcoma, or melanoma that has progressed to an advanced or metastatic stage - Your cancer has progressed on or you are intolerant to standard treatments - You have measurable disease on imaging - Your overall health and organ function are adequate **You may NOT be eligible if...** - You have had another invasive cancer in the past 2 years - You have active autoimmune disease requiring treatment - You have received certain prior immunotherapy treatments recently - You have brain metastases that are not stable - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOR502

IgG1 monoclonal antibody that binds specifically to the LILRB2 protein.

DRUGCemiplimab

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


Locations(4)

NEXT Austin

Austin, Texas, United States

NEXT Dallas

Irving, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06090266


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