Early 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 who are able to understand and willing to sign a consent form
• People with a confirmed diagnosis of pancreatic adenocarcinoma (a specific type of pancreatic cancer) that is classified as resectable, borderline resectable, locally advanced, or metastatic (note: people whose cancer may be removable by surgery might not be eligible for all parts of the trial)
• People who have not yet had treatment for their pancreatic cancer, or who have had prior treatment — provided at least 10 days have passed since finishing the most recent treatment
• People who have at least one tumour area that a doctor can safely take a small tissue sample (biopsy) from
• People who have a general health and activity level rated as reasonably functional, based on a standard medical scale (ECOG score of 0–2)
• People whose blood test results meet certain minimum levels for red blood cells, white blood cells, infection-fighting cells (neutrophils), and platelets — checked within 4 weeks before starting treatment (the trial team will review borderline results on a case-by-case basis)
• People whose kidney function blood tests are within acceptable ranges, checked within 4 weeks before starting treatment (confirm with trial site)
• People whose liver function blood tests — including bilirubin and liver enzymes — are within acceptable ranges, checked within 4 weeks before starting treatment
• People who are willing and able to have tumour biopsies taken as required during the trial
• People who are able to swallow tablets or capsules
• People who are willing and able to attend all required visits, treatments, and follow-up appointments for the duration of the trial
• People who have had another type of cancer in the past may still be considered if it was a treated skin cancer (basal or squamous cell), a non-invasive breast or cervical cancer, or any other cancer treated with curative intent with no signs of return for at least 6 months
• People with hepatitis C virus infection may be considered if they have completed curative treatment, or if their liver disease is classified as Child's Pugh A (confirm with trial site)
• People with HIV may be considered if their immune cell count (CD4) is at or above 350, their HIV viral load is below 25,000 IU/ml, and they are on a stable HIV treatment regimen
• People of childbearing potential must have a negative pregnancy test within 72 hours before the first dose of study treatment
• People must agree to use adequate contraception throughout the trial, for a period specific to whichever study drug they are assigned

Who may not be able to join:

• People whose tumour cannot be safely accessed for a biopsy
• People whose other health conditions make the risks of surgery too high, as determined by the treating institution
• People who have had major surgery within 4 weeks, or minor surgery within 2 weeks, before starting the trial, or who have not yet recovered from surgery
• People currently taking certain medications that strongly or moderately affect how the body processes drugs (known as CYP3A inducers or inhibitors — examples include rifampicin, itraconazole, clarithromycin, and St John's Wort; confirm full list with trial site)
• People currently receiving other cancer treatments such as chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or biological therapy (palliative radiotherapy may be an exception — confirm with trial site)
• People with a known severe allergy or sensitivity to the study drug(s) or similar medications
• People with significant heart problems, including poorly controlled heart failure, uncontrolled high blood pressure, a heart rhythm problem requiring medication, a heart attack or unstable chest pain within the past 6 months, or an abnormal heart electrical reading (QTc interval above the acceptable threshold, or a condition called congenital long QT syndrome)
• People who are pregnant or breastfeeding, or who plan to conceive a child within 120 days after the last dose of trial treatment
• People who have difficulty swallowing or absorbing oral medications due to a digestive condition
• People with an active, uncontrolled infection that has not improved with appropriate treatment
• People with psychiatric or social circumstances that would make it difficult to follow the trial requirements
• For the Azenosertib part of the trial specifically:
  • People who have previously been treated with a type of drug called a WEE1 inhibitor
  • People who have had major surgery within 28 days, radiation therapy within 21 days (unless a very small area was treated), or a stem cell transplant within 3 months before starting treatment
  • People with cancer that has spread to the brain and is causing symptoms, or cancer that has spread to the lining of the brain or spinal cord and needs immediate treatment
  • People with significant digestive problems, ongoing severe diarrhoea or vomiting, or who cannot take oral medication
  • People with an active or uncontrolled infection (those being treated for infection may be considered if they have been stable and fever-free for at least 72 hours)
  • People whose heart electrical reading (QTcF) is above 480 ms, or who have a personal or family history of a heart rhythm condition called long QT syndrome or Torsade de Pointes
  • People with unresolved side effects from prior treatments that are above a mild level (with some exceptions such as nerve-related symptoms or hair loss — confirm with trial site)
  • People with a known sensitivity to drugs similar to Azenosertib
  • People currently taking medications that can significantly prolong the heart's QT interval
  • People currently taking strong or moderate CYP3A4 inhibitors or inducers, or certain drug-transport inhibitors (confirm full list with trial site)
  • People must avoid eating certain citrus fruits — including grapefruit, Seville oranges, pomelos, and related hybrids — from 7 days before starting the study drug and throughout the entire study (regular orange juice is permitted)
• For the AZD5305 part of the trial specifically:
  • People with a known allergy to AZD5305 or its ingredients
  • People with a blood or bone marrow condition called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML), or signs suggestive of these conditions
  • People with cardiovascular disease, a QTc reading above 450 ms, or factors that increase the risk of heart rhythm problems
  • People with a history of severely low blood counts lasting more than 2 weeks for any reason
• For the Tremelimumab part of the trial specifically:
  • People who have previously received immunotherapy for their pancreatic cancer
  • People with unresolved side effects above a moderate level from prior treatment
  • People with a history of certain lung conditions, including pulmonary fibrosis, drug-induced lung inflammation, or active lung disease diagnosed in the past 6 months
  • People with an active or previously diagnosed autoimmune or inflammatory disorder

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