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:

• Adults aged 18 or older at the time of signing the consent form.
• People with an advanced or metastatic solid tumour (one that has spread or cannot be cured) that has stopped responding to standard treatments, or where standard treatments are not tolerated. Specific cancer types being studied include non-small cell lung cancer, triple-negative breast cancer, head and neck cancer, prostate cancer, colorectal cancer, pancreatic cancer, bile duct cancer, high-grade ovarian cancer, a type of lymphoma called diffuse large B cell lymphoma, kidney cancer, and bladder/urinary tract cancer. Other cancer types may be considered with sponsor approval.
• People whose tumour has a specific targetable genetic mutation must have already tried all approved targeted treatments, or have a medical reason those treatments cannot be used.
• People whose cancer can be measured on a CT, PET/CT, or MRI scan according to standard research criteria (called RECIST 1.1). Some exceptions for non-measurable disease may be considered in the first part of the trial with special approval.
• People with a good general health and activity level, scored 0 or 1 on a standard scale used in cancer research (called ECOG performance status). People with kidney cancer being placed in a specific group may score up to 2.
• People whose blood counts meet minimum levels: haemoglobin at least 9 g/dL, neutrophils (a type of white blood cell) at least 1.0 × 10⁹/L, and platelets at least 75 × 10⁹/L — without having received blood transfusions or certain growth factor medicines in the two weeks before testing.
• People whose liver is functioning adequately, based on blood test results within accepted ranges (confirm specific values with the trial site).
• People whose kidneys are functioning at an estimated clearance rate of at least 30 mL/minute.
• Women who could become pregnant and men whose partners could become pregnant must agree to use contraception from the time of signing the consent form until at least 4 months after the last dose of trial treatment.
• People with suitable veins for safe administration of the trial drug and blood sampling.
• People for whom stored tumour tissue (biopsy) from a previous procedure is available or can be located. If no stored tissue is available, participation may still be possible in the first part of the trial (confirm with trial site).
• People who are willing to have a fresh tumour biopsy taken before treatment begins, where this is considered safe (this is strongly encouraged in Part 1 and required in Part 2 unless the risk is too high or the person declines, after discussion with the trial team).

Who may not be able to join:

• People who have not yet recovered from side effects of previous cancer treatments (such as surgery or radiotherapy) to a mild or baseline level, with the exception of hair loss and nerve-related symptoms in the hands or feet.
• People with brain metastases (cancer that has spread to the brain) that are not stable or not well controlled. People with previously treated and stable brain metastases, confirmed by recent imaging, may be eligible if they require only a low dose of steroid medication (confirm with trial site).
• People who received wide-area radiotherapy within 4 weeks before starting the trial, or limited palliative radiotherapy within 2 weeks, and have not recovered from related side effects.
• People with an active infection that requires antibiotic treatment at the time of the first dose. People on oral antibiotics may be considered after discussion with the trial medical team.
• People with a serious uncontrolled medical condition that the treating doctor or trial medical team believes would make participation unsafe or difficult.
• People with a psychiatric illness or personal situation that would make it difficult to follow the trial requirements, or that could increase health risks, or affect the ability to give informed written consent.
• People with another active invasive cancer, apart from certain low-risk or localised conditions such as stable prostate cancer under monitoring, cervical cancer in situ, breast cancer in situ, or localised non-melanoma skin cancer.
• People with significant uncontrolled heart disease, classified as Grade III or IV by standard heart disease guidelines.
• People with an abnormal heart rhythm measurement (QTc interval above 470 milliseconds) who do not have a pacemaker.
• People with an active autoimmune disease requiring systemic treatment with immune-modifying medicines, corticosteroids above 10 mg/day of prednisone equivalent, or any dose of immunosuppressive drugs. (Hormone replacement therapies and certain low-dose or localised steroid treatments are generally not considered systemic treatment — confirm specifics with the trial site. People with controlled type 1 diabetes on stable insulin, or those with vitiligo, may still be eligible.)
• People who have taken immunosuppressive medicines (such as prednisone at 10 mg/day or more, or certain immune-blocking medicines) within 28 days before the planned first dose. Short-term use of low-dose steroids (less than 10 mg prednisone per day) may be acceptable.
• People who previously stopped a type of cancer immunotherapy (called immune checkpoint therapy) because of immune-related side effects, regardless of how severe those side effects were or whether they recovered. People whose immune-related side effects have not resolved to a mild level, or who still need higher-dose steroids to manage them, are also not eligible.
• People with a history of a type of lung inflammation called interstitial lung disease or pneumonitis (including immune-related or radiation-related), active tuberculosis of the lung, or signs of active lung inflammation on a recent chest scan. People who received high-dose radiation to the lung within the past 6 months are also excluded, as are people with an active lung infection requiring treatment.
• People who have received a live vaccine within 30 days before enrolling in the trial.
• People with known active hepatitis B or C infection.
• People who are HIV-positive may only be considered for Part 2 of the trial and must meet specific criteria related to immune cell counts, absence of recent serious infections, stable HIV treatment, and low viral load (confirm details with the trial site). People with other significant immune deficiency conditions are not eligible.
• People with a known or suspected allergy to the trial drug or its ingredients.
• People who have previously received a bone marrow transplant from a donor or an organ transplant.
• People being considered for the toripalimab treatment group must not have any medical reason listed in the toripalimab prescribing information that would prevent its use.

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