Study of OT-101 with mFOLFIRINOX for Advanced Pancreatic Cancer

Inclusion Criteria

• Must have advanced pancreatic cancer that cannot be removed by surgery or has spread, confirmed by a biopsy.
• Must have measurable disease according to specific medical criteria.
• Must be 18 years or older and not pregnant or breastfeeding.
• Women of childbearing age must have a negative pregnancy test and agree to use birth control during the study and for 9 months after the last dose of OT-101.
• Men must agree to use effective contraception for 6 months after the last dose.
• Must provide written informed consent to participate.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must be willing and able to follow study requirements.
• Must have adequate organ function based on specific blood tests.
• Must have a life expectancy of at least 3 months according to the study doctor.

Exclusion Criteria

• Cannot have other types of pancreatic cancer or cancers originating from other areas like the biliary tree.
• Cannot have a decrease in performance status between screening and the start of the study.
• Cannot be on certain blood thinners unless willing to switch to an approved alternative.
• Cannot have had another cancer within the last 3 years, except for certain skin cancers or other cancers that are well-controlled.
• Cannot have serious medical conditions or psychiatric illnesses that would interfere with the study.
• Cannot have abnormal heart rhythms or other significant heart issues.
• Cannot have uncontrolled infections or a history of certain viral infections like HIV or hepatitis.
• Cannot have had significant bleeding issues recently.
• Cannot be pregnant or breastfeeding.
• Cannot have had recent heart attacks or other serious heart conditions.
• Cannot have significant fluid buildup in the abdomen requiring frequent drainage.
• Cannot have had major surgery recently or plan to have surgery during the study.
• Cannot have received certain immune therapies before.
• Cannot have severe nerve damage.
• Cannot have a known deficiency in a specific enzyme that affects drug metabolism.
• Cannot have a history of autoimmune diseases, except for certain conditions that are well-controlled.
• Cannot be taking certain medications that interfere with the study drugs.
• Cannot have allergies to similar drugs as OT-101.
• Must be able to attend follow-up visits and comply with study procedures.
• Cannot be participating in another clinical trial recently.
• Cannot have significant psychiatric disorders or legal incapacity.
• Cannot have a primary immune deficiency.
• Cannot have active cancer spread to the brain unless it has been treated and stable for at least 6 weeks.