Phase 2 Pancreatic Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People who are able to understand what the study involves and are willing to sign a written consent form agreeing to take part
• People who have been confirmed by a tissue or cell sample test to have pancreatic adenocarcinoma (a type of pancreatic cancer) that has either spread to nearby areas and cannot be surgically removed, or has spread to other parts of the body
• People who have completed between 16 and 32 weeks of a standard first-line chemotherapy treatment, where that treatment resulted in the tumour shrinking or staying stable, with no signs of the cancer getting worse in the 14 days before the first study dose — or, if chemotherapy was stopped early for valid medical reasons, those who showed stable or shrinking disease before stopping
• People whose side effects from chemotherapy have cleared up to pre-treatment levels, except for hair loss (which may still be ongoing) and nerve-related symptoms (which may still be present at a mild-to-moderate level)
• People with a general health and activity level rated 0 or 1 on a standard medical scale, meaning fully active or able to carry out light work (confirm with trial site)
• People who have at least one area of disease that can be measured on a scan, according to standard imaging guidelines
• People who are willing to have tumour tissue samples (biopsies) taken before and during treatment, unless a doctor determines this is not medically safe
• People whose blood test results from within 14 days before the first dose show that the liver, kidneys, and blood counts are working adequately (confirm with trial site for specific values)
• Women who could become pregnant must have a negative pregnancy test within 14 days before starting treatment, and must agree to use approved contraception or complete abstinence during treatment and for at least 120 days after the last dose
• Men must agree to use a condom during any sexual contact with a woman who is pregnant or could become pregnant, during treatment and for at least 120 days after the last dose, even if they have had a vasectomy

Who may not be able to join:

• People who have previously been treated with a type of drug called a CD40 antibody, or any other drug that works by modifying the immune system to treat cancer
• People who have previously been treated with a drug called odetiglucan
• People who have received any systemic cancer treatment within 14 days before the first study dose, or, for experimental treatments, within a period based on how long that drug stays active in the body
• People who have had an active or inactive autoimmune disease (where the immune system attacks the body) that needed systemic treatment in the past 2 years, or who currently need ongoing systemic treatment for such a condition — note that some milder or well-controlled conditions such as controlled asthma, psoriasis not requiring systemic treatment, vitiligo, stable thyroid conditions, or Type I diabetes may still be eligible (confirm with trial site)
• People who have an ongoing active infection requiring intravenous antibiotics, antiviral, or antifungal treatment in the 14 days before the first study dose
• People with a serious uncontrolled illness, including severe heart failure, unstable chest pain (angina), uncontrolled high blood pressure, or an irregular heartbeat
• People with a history of non-infectious lung inflammation that needed steroid treatment, current lung inflammation, or a history of scarring of the lung tissue
• People with a heart electrical reading (QT interval) above a certain level on an ECG test (confirm with trial site for specific values)
• People who have had a heart attack within the past 6 months, or a blood clot in an artery within the past 3 months before the first study dose
• People with a history of HIV, hepatitis B, or hepatitis C — though certain people with previously resolved or treated hepatitis B or C, with specific test results showing the virus is no longer detectable, may still be considered eligible (confirm with trial site)
• People who have used immune-suppressing medications within 14 days before the first study dose — though some low-dose steroids and locally applied steroids (such as nasal sprays, skin creams, or eye drops) may be permitted (confirm with trial site)
• People with known brain or spinal fluid metastases (cancer that has spread to the brain or the fluid around the spine) that are causing symptoms
• People who have had major surgery within 21 days before the first study dose, or minor surgery requiring local or spinal anaesthesia within 72 hours before the first dose
• People with another active cancer, except for certain fully treated skin cancers or cancers from which the person has been cancer-free for at least 3 years
• People who have received a live vaccine within 28 days before the first study dose — note that standard injected flu vaccines are generally permitted, but nasal spray flu vaccines are not
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with a known problem with alcohol or drug misuse
• People with a significant psychiatric, social, or medical condition that, in the treating doctor's opinion, could increase health risks, make it difficult to follow the study requirements, or affect the ability to give informed consent

Important: Always verify eligibility with the trial site directly before applying.