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Odetiglucan + CD40 Agonist for Pancreatic Cancer
Study Summary
This trialwill test a new drug combo to treat advanced pancreatic cancer, assessing safety, effectiveness and side effects.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My kidney function tests are within the required range.I've had 16-32 weeks of first-line chemotherapy with no cancer progression.I have never been treated with CD40 antibodies or similar immune-based treatments for cancer.My blood clotting time is normal or managed with medication.I do not have a known or suspected spinal cord or brain lining disease.I have a history of HIV, hepatitis B, or hepatitis C.I am over 18, understand the study, and agree to all its requirements.I am using corticosteroids that don't significantly enter my bloodstream.I have been treated with odetiglucan before.I have not had chemotherapy in the last 14 days.I had hepatitis C but it's now undetectable.I am fully active or restricted in physically strenuous activity but can do light work.I am taking low-dose steroids, not more than 10 mg of prednisone.I do not have any severe illnesses like heart failure, uncontrolled diabetes, or serious infections.I have not had a heart attack or blood clot in the arteries in the last 6 months.I have not had major surgery within the last 4 weeks.I may need steroids, but it depends on my doctor's approval.I haven't had a live vaccine in the last 28 days and won't get one during or for 30 days after the study.I've been cancer-free for 3 years, except for minor skin cancers or in situ cancers.I can understand and am willing to sign the consent form.My pancreatic cancer has spread and was confirmed by a lab test.My blood clotting time is within safe limits, or I'm stable on my blood thinner with no bleeding.All my side effects from chemotherapy have gone except for hair loss and mild nerve pain.I have antibodies against hepatitis B but no active virus.I have brain metastases that haven't been treated.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I have or had lung inflammation not caused by an infection.I haven't taken immunosuppressive drugs in the last 14 days, except for allowed exceptions.I have not needed systemic treatment for an autoimmune disease in the last 2 years.I agree to use two effective birth control methods if I'm of childbearing potential or with someone who is.
- Group 1: Part B
- Group 2: Part A
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA sanctioned Part B for medicinal use?
"The safety rating of Part B was set at 1 based on the findings from its Phase 1 trial, as there is only minimal data for both efficacy and security."
Is recruitment for this research endeavor currently available?
"Affirmative. Data archived on clinicaltrials.gov validates that this research, which was initially posted in December 15th of 2022, is currently recruiting patients to participate. 30 people must be accepted from 2 sites for the study to move forward."
How many participants are enrolled in this clinical experiment?
"Affirmative. The clinical trial, which first appeared on December 15th 2022, is actively recruiting according to the information posted on clinicaltrials.gov. As of 1/13/2023, 30 individuals need to be recruited from 2 separate medical centres for this study."
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