Study on OR2805, a Monoclonal Antibody Targeting CD163, Alone and with Other Cancer Treatments

Sponsor: OncoResponse, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05094804

Provider View

This clinical trial is testing a new drug called OR2805, which is a type of antibody, to see if it is safe and effective in treating advanced solid tumors. The study will look at OR2805 both by itself and in combination with other cancer treatments.

Patient Parameters

Program Overview

This study is designed to test the safety and effectiveness of a new drug called OR2805, which is a monoclonal antibody targeting CD163. The trial will involve patients with advanced solid tumors and will be conducted in multiple parts. The first part will determine the best dose of OR2805, either alone or with other cancer drugs. The second part will expand the study to include more patients with specific types of cancer, such as melanoma and non-small cell lung cancer, to further assess the drug's safety and effectiveness. The third part will explore how the drug works in the body and identify potential markers that predict response to treatment.

Description

This clinical trial is divided into three parts:

  • Part A: This phase will test different doses of OR2805 to find the safest and most effective dose when used alone or with other cancer drugs like cemiplimab or docetaxel. Up to 54 patients with various types of advanced cancer will participate.

  • Part B: This phase will include patients with melanoma or non-small cell lung cancer (NSCLC) to further evaluate the safety and effectiveness of OR2805, either alone or with other drugs. Each group will have about 20 patients.

  • Part C: This phase will focus on understanding how OR2805 works in the body and identifying markers that might predict how well patients respond to the treatment. It will include up to 40 patients with specific cancers like liposarcoma, leiomyosarcoma, or squamous cell carcinoma of the head and neck (SCCHN). All patients in this part will have biopsies taken.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 to 100 years old.
  • Must have a confirmed diagnosis of advanced cancer that cannot be treated with local therapy.
  • Must have tried standard cancer treatments without success or be unable to receive them for medical reasons.
  • Must have measurable cancer that can be tracked during the study.
  • Must agree to use effective birth control during the study and for three months after.
  • Must have stable health with no severe side effects from previous treatments.
  • Must be able to provide a tumor sample for analysis.
  • Must be willing to follow the study procedures and attend all appointments.

Exclusion Criteria

  • Have had a severe allergic reaction to similar treatments.
  • Have a life expectancy of less than 12 weeks.
  • Have had an organ or stem cell transplant.
  • Have active cancer in the brain or spinal cord, unless treated and stable.
  • Have a history of another type of cancer unless treated and disease-free for at least three years.
  • Have a serious infection or uncontrolled HIV, hepatitis B, or hepatitis C.
  • Have an autoimmune disease requiring treatment.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Are currently taking other cancer treatments, except for certain hormonal therapies.

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