Phase 1 Peripheral Neuropathy 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 who are able to understand the study, agree to take part voluntarily in writing, and are willing to follow all study requirements such as scheduled visits, tests, and procedures.
• People who are 18 years of age or older.
• People who have been diagnosed with advanced, returning, or spread (metastatic) pancreatic cancer that has been confirmed by a pathology test, and who have not yet received any systemic (whole-body) treatment for the advanced or metastatic stage of their cancer.
• People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines (confirm with trial site).
• People who have stored tumour tissue samples available, or who are willing to have a fresh tumour biopsy taken before treatment starts, so the tumour can be tested for certain molecular features.
• People whose blood test results show that bone marrow, liver, and kidney function are within acceptable ranges set by the trial (confirm with trial site for specific values).
• People whose blood levels of pancreas-related enzymes (amylase and lipase) are within an acceptable range (confirm with trial site).
• People who are generally well enough to carry out normal daily activities, rated as ECOG performance status 0 or 1 — meaning fully active or restricted only in physically strenuous activity (confirm with trial site).
• People who have had focal radiation therapy, or surgery under general or local anaesthetic, at least 7 days before the first study treatment dose.
• People who received fluorouracil or gemcitabine as a radiation sensitiser after surgery, as long as that treatment finished at least 6 months before enrolling in this trial.
• People who received neoadjuvant chemotherapy with FOLFIRINOX before surgery, as long as that treatment finished at least 6 months before enrolling.
• People who received chemotherapy after surgery (adjuvant chemotherapy), as long as that treatment finished at least 6 months before enrolling.
• Women who could become pregnant must have a negative pregnancy test (blood or urine) within 72 hours before the first study treatment, must not be breastfeeding or planning to become pregnant during the study, and must agree to use effective contraception (hormonal and barrier methods, or complete abstinence) during the study and for 9 months after finishing treatment.
• Male participants with partners who could become pregnant must agree to use barrier contraception or complete abstinence from the screening period until 9 months after finishing treatment.
• People who are not currently taking part in any other trial involving an experimental medicine.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People with a known allergy or sensitivity to any component of the study drugs (9-ING-41, the chemotherapy agents used, or the PD-1 inhibitor retifanlimab).
• People who have previously been treated with any anti-PD-1, PD-L1, or PD-L2 therapy (a type of immunotherapy).
• People whose pancreatic cancer is of the endocrine or acinar type.
• People who have not fully recovered from significant side effects caused by previous cancer treatments (with the exception of hair loss, mild anaemia not needing transfusion, and infertility).
• People with significant heart problems, including a history of moderate-to-severe heart failure, unstable chest pain (angina), stroke within the past 6 months, or a heart rhythm problem requiring medication that was found at screening.
• People who have had a heart attack within the past 12 weeks, or who have heart tracing (ECG) abnormalities considered medically significant by the treating doctor.
• People with brain metastases (cancer that has spread to the brain) or involvement of the membranes around the brain that are rapidly worsening or causing symptoms. People with stable or slowly progressing brain involvement may be considered eligible, provided they have not needed new treatments for it in the past 28 days and have been on stable doses of anti-seizure medicines and steroids for at least 14 days (confirm with trial site).
• People who have had major surgery within 7 days before joining the study, or who are expected to need major surgery during the trial (confirm with trial site for definition of major surgery).
• People with any medical or personal circumstances that, in the opinion of the trial doctor, would prevent safe study participation.
• People who have taken an experimental anti-cancer drug within 14 days (or within 5 half-lives of that drug, whichever is longer) before the first study dose, or who are currently in another interventional clinical trial.
• People who currently have another active cancer other than pancreatic cancer.
• People with a known immune deficiency condition, an active autoimmune disease, or who require immune-suppressing medicines at doses higher than low-level (maintenance) steroid doses (greater than 10 mg per day of prednisone or equivalent). Note: certain low-dose or localised steroid uses may be permitted — confirm with trial site.
• People with evidence of, or a history of, a lung condition called interstitial lung disease, or active non-infectious lung inflammation (pneumonitis).
• People who have received palliative radiation therapy within 1 week of the first study dose, or high-dose radiation (more than 30 Gy) within 6 months of the first study dose.
• People who have received systemic antibiotics within 7 days before the first study dose.
• People who have had an organ transplant, including a bone marrow (stem cell) transplant.
• People with a known severe allergy to another monoclonal antibody (a type of medicine) that cannot be managed with standard treatments such as antihistamines or steroids.
• People who have received a live vaccine within 28 days before the planned start of study treatment.
• People with a known history of a specific genetic variation called UGT1A1 gene polymorphism (confirm with trial site).

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