Study on Combined AlloStim and Anti-PD-L1 Therapy for Advanced Metastatic Colorectal Cancer

Sponsor: Mirror Biologics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06557278

Provider View

This clinical trial is testing a new combination treatment using AlloStim and an anti-PD-L1 drug for patients with advanced metastatic colorectal cancer that has not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if a new combination of treatments, AlloStim and an anti-PD-L1 drug, can help patients with advanced metastatic colorectal cancer that has not responded to other treatments. The treatment involves giving AlloStim in cycles, followed by a combination of AlloStim and an anti-PD-L1 drug, to see if it can make the cancer more responsive to immunotherapy.

Description

This study is for patients with advanced colorectal cancer that has not responded to standard treatments. The treatment involves using AlloStim, an experimental therapy, in combination with an anti-PD-L1 drug. The goal is to see if this combination can make the cancer more responsive to immunotherapy. Patients will receive AlloStim in cycles, with doses given under the skin and through an IV. After the initial treatment, a CT scan will be done to check for changes in the cancer. The study will also look at how the treatment affects the immune system and if it can help the body fight the cancer more effectively. Patients who respond well to the initial treatment may receive additional cycles of the combination therapy.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18-80 years old.
  • Diagnosed with a specific type of colorectal cancer that has spread.
  • Cancer has not responded to at least two previous chemotherapy treatments.
  • If the cancer is on the left side and KRAS wild type, must have tried anti-EGFR therapy.
  • Cancer has not responded to or is not suitable for at least one third-line treatment.
  • Good overall health with a performance score of 0-1.
  • Adequate blood cell counts and organ function.
  • Women must not be pregnant or breastfeeding and must use effective birth control.
  • Must be able to provide informed consent.

Exclusion Criteria

  • Certain genetic types of colorectal cancer.
  • Bowel obstruction or risk of obstruction.
  • Moderate or severe fluid buildup in the abdomen.
  • Cancer spread to the brain or spinal fluid.
  • Extensive cancer spread in the abdomen.
  • Chronic obstructive pulmonary disease (COPD).
  • Lung issues requiring treatment or low oxygen levels.
  • Certain mood disorders or recent suicidal thoughts.
  • Previous organ or stem cell transplant.
  • Long-term use of high-dose steroids.
  • Active autoimmune diseases, except well-controlled Type I diabetes.
  • Previous experimental immunotherapy.
  • History of blood transfusion reactions.
  • Active infections that are not resolved.
  • Heart disease with symptoms.
  • HIV or AIDS.
  • Severe allergies to monoclonal antibody drugs.
  • Psychiatric or addiction issues that prevent participation.
  • Unable to provide consent.
  • Other active cancers, except certain types that are cured or non-threatening.

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