Study on Ontegimod and Gemcitabine/Nab-paclitaxel as Second Line Treatment for Advanced Pancreatic Cancer

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06904378

Provider View

This clinical trial is testing a new combination of drugs, Ontegimod with gemcitabine and nab-paclitaxel, to see if it can help treat advanced pancreatic cancer that cannot be removed by surgery. The study aims to find out if this combination can make the cancer more responsive to future immunotherapy treatments.

Patient Parameters

Program Overview

The purpose of this study is to test if a new drug combination, Ontegimod with gemcitabine and nab-paclitaxel, can help treat advanced pancreatic cancer that has not responded to initial treatments. Researchers believe that Ontegimod may change the environment around the tumor to make it more responsive to future immunotherapy. This study is open to patients with pancreatic cancer that cannot be surgically removed and who need a new treatment option after their first treatment stopped working.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic cancer confirmed by lab tests.
  • Have cancer that can be measured or evaluated by scans.
  • Have tumors that can be safely biopsied for research purposes.
  • Previously treated with one type of systemic therapy for advanced pancreatic cancer, but it stopped working or was not tolerated.
  • Be at least 18 years old.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1.5 K/cumm.
    • Platelet count of at least 100 K/cumm.
    • Hemoglobin level of at least 9.0 g/dL.
    • Liver and kidney function within specified limits.
  • Agree to use effective contraception during the study and for a specified period after the last dose of study drugs.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Have received more than one line of treatment for advanced pancreatic cancer or have been treated with gemcitabine or nab-paclitaxel in the metastatic setting.
  • Currently using or planning to use alternative or holistic treatments for cancer.
  • Have had major surgery within 28 days before starting the study treatment.
  • Have received chemotherapy or radiation therapy within 14 days before starting the study treatment.
  • Have a history of other cancers, except for certain non-threatening cancers treated at least two years ago.
  • Have had an organ or stem cell transplant.
  • Currently participating in another clinical trial.
  • Have untreated brain metastases.
  • Have allergies to the study drugs or similar compounds.
  • Have certain heart conditions or gastrointestinal issues that affect drug absorption.
  • Have significant nerve damage or uncontrolled illnesses.
  • Are pregnant or breastfeeding.
  • Have certain viral infections like HIV, hepatitis B, or hepatitis C that are not well-controlled.
  • Have active autoimmune diseases or require high doses of steroids or immunosuppressive medications.
  • Have Gilbert's syndrome.

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