A Pilot Study of BXCL701 in Patients With Pancreatic Cancer

Exclusion Criteria

• •1. A female who is pregnant or breast-feeding.
• •2. Has other concurrent malignancies except for basal and squamous cell cancers of the skin and in-situ cervical cancer.
• •3. Has uncontrolled epilepsy, central nervous system diseases, or a history of mental disorder that is severe enough to hinder the ability of the patient to provide informed consent or that may influence the patient's compliance with the protocol in the judgments of the investigator.
• •4. Has an upper gastrointestinal obstruction, abnormal physiological function, or malabsorption syndrome that may affect the absorption of study medication.
• •5. Has required chronic corticosteroids, defined as \> 10 mg/day of prednisone or equivalent, or immunosuppressive therapy within the past 3 months. Patient requires treatment with DPP4 inhibitors (e.g. gliptins).
• •6. Has a premalignant hematologic disorder, eg, myelodysplastic syndrome.
• •7. Has a severe organ dysfunction or disease that might prevent completion of the treatment regimen, eg, cardiopulmonary diseases (New York Heart Association \[NYHA\] ≥ Class III, arrhythmia Lown III/IV, global respiratory insufficiency); ascites; acute pancreatitis; bleeding diathesis, coagulopathy, or need for full dose anticoagulation.
• •8. Has a chronic infectious disease, especially immune deficiency syndromes, eg, human immunodeficiency virus (HIV) infection, active tuberculosis within 12 months prior to potential study participation or suspected/active SARS-CoV-2 (Covid-19) infection.
• •9. Has a history of severe neurologic disorders, eg, cerebrovascular ischemia within the past year.
• •10. Has a history of prior deep venous thrombosis or pulmonary embolism within the past year.
• •11. Has serious medical, psychological, familial, sociological, or geographical conditions or circumstances potentially hampering compliance with the study protocol and follow-up.
• •12. QT interval corrected for heart rate using Bazett's formula (QTcB) \> 440 msec at Screening.
• •13. Patients with history of symptomatic orthostatic hypotension within 3 months prior to enrollment. Orthostatic hypotension is defined as a drop in systolic blood pressure (BP) of ≥ 20 mmHg or diastolic BP of ≥ 10 mmHg with assumption of an upright posture