Study on OR502, a Monoclonal Antibody Targeting LILRB2, Alone and with Other Cancer Treatments

Sponsor: OncoResponse, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06090266

Provider View

This clinical trial is testing a new drug called OR502, both by itself and with another cancer drug, cemiplimab, to see if it is safe and can help treat advanced solid tumors. The study will help determine the best dose and how well the treatment works.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of a new drug, OR502, which is a type of antibody that targets a specific protein called LILRB2. The trial is for people with advanced solid tumors and is divided into two parts. The first part will find the best dose of OR502, either alone or with cemiplimab, by gradually increasing the dose in a small group of participants. The second part will expand the study to more participants to further test the safety and effectiveness of OR502 at two different doses, both alone and with cemiplimab, especially in patients with certain types of cancer like ovarian cancer and skin cancer.

Description

This clinical trial is designed to test the safety and effectiveness of OR502, a new antibody treatment, in people with advanced solid tumors. The study has two main parts:

  • Part A: This phase will gradually increase the dose of OR502 to find the highest safe dose when used alone and with cemiplimab. Up to 48 participants will be involved.

  • Part B: This phase will expand the study to include more participants, testing OR502 at two different doses, both alone and with cemiplimab. This part will focus on patients with advanced ovarian cancer and skin cancer that have not responded to other treatments. Up to 120 participants will be involved.

The study aims to find the best dose for future research and to see how well the treatment works against tumors. Participants will be closely monitored for side effects and how their cancer responds to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced solid tumors, such as carcinoma, sarcoma, or melanoma, that cannot be treated with surgery.
  • Have tried standard cancer treatments without success or cannot tolerate them.
  • Have measurable disease that can be tracked during the study.
  • Women of childbearing potential must agree to use effective birth control during the study and for four months after.
  • Must have stable health conditions and adequate organ function.
  • Must be willing to provide a tumor sample for research purposes.
  • Must be able to understand and agree to the study requirements.

Exclusion Criteria

  • Have had a severe allergic reaction to similar treatments.
  • Have a life expectancy of less than 12 weeks.
  • Have a poor performance status, meaning they are unable to carry out daily activities.
  • Have had an organ or stem cell transplant.
  • Have active brain tumors or untreated brain metastases.
  • Have a history of other cancers unless treated and in remission for at least three years.
  • Have serious infections or uncontrolled HIV, hepatitis B, or hepatitis C.
  • Have autoimmune diseases requiring systemic treatment.
  • Are pregnant or breastfeeding.
  • Are unable to comply with the study requirements or have a history of substance abuse.

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