Study on Nab-Paclitaxel and Gemcitabine With or Without SBP-101 for Pancreatic Cancer

Inclusion Criteria

• Diagnosed with metastatic pancreatic ductal adenocarcinoma.
• Not previously treated for metastatic pancreatic cancer, with diagnosis made within the last 3 months.
• Expected to receive standard treatment with gemcitabine and nab-paclitaxel.
• May have had prior surgery or chemotherapy for earlier stages of cancer.
• Life expectancy of at least 3 months.
• Cancer that can be measured by CT or MRI scans.
• Good overall health with an ECOG performance status of 0 or 1.
• Aged 18 years or older, male or female.
• Women of childbearing potential must have a negative pregnancy test and use effective contraception during and after the study.
• Adequate bone marrow, liver, and kidney function.
• Specific heart function criteria met on an ECG test.
• Willing to provide written informed consent to participate in the study.

Exclusion Criteria

• Known mutations in BRCA 1/2 genes.
• Taking metformin for diabetes, which must be stopped before the study.
• History of eye problems like retinopathy or risk factors for retinal detachment.
• Severe or uncontrolled diseases that make participation unsafe.
• Medical or psychiatric conditions affecting consent or study completion.
• Other types of pancreatic tumors or mixed cancer types.
• Active cancer in the brain or central nervous system.
• Low serum albumin levels.
• Recent blood clots or thromboembolic events.
• Active infections requiring treatment.
• Known infections with HIV, hepatitis B, or C.
• Lung diseases like interstitial lung disease or pulmonary fibrosis.
• Recent heart attack or severe heart conditions.
• Pregnant or breastfeeding women.
• Recent major surgery without full recovery.
• Allergies to study drugs.
• Participation in another clinical trial recently.
• History of using hydroxychloroquine.