Phase 1 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:

• People aged 18 or older at the time of signing the consent form.
• People who have been diagnosed with pancreatic adenocarcinoma (a specific type of pancreatic cancer) that has spread to other parts of the body (stage IV), confirmed by a tissue or cell sample.
• For the first part of the trial (dose escalation): people whose doctors consider them suitable to receive the chemotherapy drugs gemcitabine and nab-paclitaxel. For the second part (dose expansion): people who have previously received a chemotherapy treatment based on a drug called 5-FU, either for their spread cancer or before/after surgery, within the past 12 months.
• People who have at least one tumour that can be safely biopsied (a small sample of tissue taken for testing).
• People whose blood test results at the screening visit fall within the required ranges for blood cell counts, kidney function, and liver function (confirm specific values with trial site).
• People who have at least one tumour that can be measured using standard imaging scans.
• People who are reasonably physically active and able to carry out daily activities, with only mild symptoms from their cancer (rated 0 or 1 on a standard scale used by doctors).
• People who have a normal heart electrical activity reading (ECG) at screening, within limits set for males and females respectively.
• Women who are not able to become pregnant — for example, those who have gone through menopause or have had a sterilisation procedure — or women who are able to become pregnant but are using a highly effective form of contraception during the study and for 6 months after the last dose of the study treatment.
• Women who are able to become pregnant must have a negative pregnancy test at screening.
• Women who are able to become pregnant must agree not to donate eggs during the study and for 6 months after the last dose of the study treatment.
• Men who are sexually active with a woman who could become pregnant, and who have not had a vasectomy, must agree to use a barrier method of contraception and must not donate sperm during the study and for 3 months after the last dose.
• People who have read, understood, and signed the informed consent form before any study-related procedures begin.

Who may not be able to join:

• People who have previously been treated with both gemcitabine and nab-paclitaxel.
• People who have significant nerve damage causing symptoms such as numbness, tingling, or weakness in the hands or feet.
• People who have untreated tumours in the brain or spinal cord, unless those tumours were treated with radiotherapy or surgery at least 4 weeks ago and have shown no signs of returning.
• People who have received certain medications used to boost blood cell production within 2 weeks before starting the study treatment (confirm specific medications with trial site).
• People with an active and unstable autoimmune disease (a condition where the immune system attacks the body). People with a well-controlled autoimmune disease may be considered after discussion with the lead doctor.
• People who have had a bone marrow or organ transplant from another person.
• People with a known history of, or current, lung disease involving scarring of lung tissue (interstitial lung disease) or non-infectious lung inflammation.
• People who have or have had another cancer, unless it was fully treated and has not come back within the past 2 years, or unless it was a completely removed skin cancer or a non-invasive cancer.
• People with a significant active infection, or a known diagnosis of HIV, hepatitis C, or hepatitis B.
• People who have received another experimental drug or used an experimental medical device within 14 days before joining, or who are currently taking part in another treatment trial.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 30 days after the last dose. Men who are planning to father a child during the study or within 30 days after the last dose are also excluded.
• People who have been hospitalised for an infection or who have had major surgery within 2 weeks before joining, or who have not fully recovered from surgery.
• People with serious heart conditions, including a heart attack in the past 6 months, uncontrolled heart failure, unstable chest pain (angina) in the past 6 months, or significant irregular heart rhythms.

The following exclusions apply only to people in the group receiving a drug called atezolizumab:

• People with an active or documented history of certain autoimmune or inflammatory conditions (such as lupus, Crohn's disease, rheumatoid arthritis, and others), with some exceptions such as vitiligo, hair loss (alopecia), well-controlled thyroid conditions, skin conditions not requiring systemic treatment, celiac disease managed by diet alone, and type 1 diabetes managed with insulin (confirm with trial site).
• People who have used immune-suppressing medications within 14 days before registration, with some exceptions such as inhaled, nasal, topical, or low-dose steroids (confirm specific exceptions with trial site).
• People who have received a live vaccine within 30 days before registration.
• People with a history of lung inflammation or scarring (pneumonitis or interstitial lung disease).

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