Phase 2 Pancreatic Cancer Trial, Recruiting

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

Who might be able to join this trial:

• A tissue or cell sample has confirmed that the person has pancreatic cancer of the type called adenocarcinoma.
• The cancer can be measured or tracked using standard imaging criteria (known as RECIST 1.1).
• The person has already received one prior treatment for pancreatic cancer that has spread or cannot be removed surgically, and that treatment either stopped working or caused side effects that made it impossible to continue — and the treating doctor believes another treatment is needed.
• The person is at least 18 years old.
• The person is generally well enough to carry out daily activities with no restriction or only minor limitations (this is assessed using a standard scale called ECOG performance status of 0 or 1).
• Blood and organ function tests meet the required levels, including adequate white blood cell counts, platelet counts, haemoglobin, liver function, and kidney function (confirm specific values with the trial site).
• People who can become pregnant, and male participants, must agree to use reliable contraception during the trial and for a set period after the last dose of study treatment.
• If a participant becomes pregnant or suspects a pregnancy has occurred during the trial, the treating doctor must be informed immediately.
• The person is able to understand the trial and is willing to sign a written consent form. A legally authorised representative may sign on their behalf if needed.

Who may not be able to join:

• People who have received more than one prior line of treatment for their pancreatic cancer, or who have previously received the chemotherapy drugs gemcitabine or nab-paclitaxel for cancer that has spread. There is a specific exception related to earlier (adjuvant or neoadjuvant) treatment depending on how long ago it was given — confirm the details with the trial site.
• People who are currently using or planning to use alternative, holistic, naturopathic, or herbal/botanical treatments specifically to treat their cancer.
• People who have had major surgery requiring general anaesthesia within 28 days before starting the trial.
• People who have received chemotherapy, targeted therapy, immunotherapy, or radiation therapy within 14 days before starting the trial.
• People with a history of another cancer, unless that cancer was fully treated at least 2 years ago with no signs of return, or unless it is a slow-growing cancer that does not need treatment and is unlikely to affect the person's care (confirm specific examples with the trial site).
• People who have had an organ transplant or stem cell transplant from another person.
• People who are currently taking part in another clinical trial using an investigational treatment.
• People who have brain metastases (cancer that has spread to the brain) that have not been treated. People whose brain metastases have been treated and show no signs of growth on follow-up imaging may still be considered.
• People who have had a significant allergic reaction to drugs with a similar makeup to the study treatments being used in this trial.
• People whose heart rhythm measurement (QTc interval) on an electrocardiogram (ECG) is above a certain threshold on average.
• People who have a digestive condition that may prevent them from properly absorbing the study drug ONT01, in the opinion of the trial doctor.
• People with significant nerve damage (peripheral neuropathy) rated as grade 2 or worse.
• People with serious uncontrolled illness, such as an active infection, heart failure, unstable chest pain, or an irregular heartbeat.
• People who are pregnant or breastfeeding. People who could become pregnant must have a negative pregnancy test within 7 days before starting the trial.
• People living with HIV who are not on effective HIV treatment with an undetectable viral load for at least 6 months.
• People with chronic hepatitis B virus (HBV) infection where the virus is still detectable, even if on suppressive treatment.
• People with a history of hepatitis C virus (HCV) infection that has not been successfully treated and cured, or where the virus is still detectable.
• People with active or suspected autoimmune disease. Some milder or well-controlled autoimmune conditions may be considered after discussion with the principal investigator (confirm with the trial site).
• People who need ongoing treatment with corticosteroids above a low dose, or other immune-suppressing medications, within 14 days before starting the trial. Short courses of steroids and inhaled, nasal, joint-injection, or skin-applied steroids may be permitted (confirm with the trial site).
• People with a condition called Gilbert's syndrome (a liver condition affecting how the body processes bilirubin).

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