Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.

Inclusion Criteria: Patients are required to meet all of the following criteria for enrollment into the study:

1. Ability to understand and willingness to provide written informed consent before anytrial-related activities.
2. Age 18 years or older.
3. Histologically or cytologically verified pancreatic adenocarcinoma.
4. Inoperable localized, locally advanced or metastatic pancreatic cancer, not amenablefor curatively intended treatment, in patients who are to be treated with gemcitabineand nab-paclitaxel.
5. Measurable or non-measurable disease determined by CT scan or MRI, according to RECIST 1.1.
6. Performance status of ECOG ≤ 2 and expected to tolerate the standard recommended (100%) gemcitabine and nab-paclitaxel dose.
7. Recovered to Grade 1 or less from prior surgery or acute toxicities of priorradiotherapy or treatment with cytotoxic or biologic agents.
8. ≥ 2 weeks must have elapsed since any prior surgery or radiotherapy.
9. Adequate conditions as evidenced by the following clinical laboratory values:

• Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
• Haemoglobin ≥ 6.0 mmol/L
• Platelets ≥ 100 x 109 /L
• Alanine aminotransferase (ALT) ≤ 2.5 x ULN and aspartate aminotransferase (AST) ≤ 2.5 x ULN*
• Total Serum bilirubin ≤ 1.0 ULN
• Alkaline phosphatase ≤ 2.5 x ULN*
• Creatinine ≤ 1.5 ULN
• eGFR within normal limits
• Adequate blood clothing function as defined by the International Normalized Ratio (INR) ≤ 1.2

10. Life expectancy longer than 3 months.
11. Sexually active males and females of child-producing potential must use highlyeffective contraception (intrauterine devices, hormonal contraceptives (contraceptivepills, implants, transdermal patches, hormonal vaginal devices or injections withprolonged release)) for the study duration and at least 6 months after the last doseof study drug.
12. Signed informed consent. *AST is not mandatory. In case of known liver metastases withALT and AST ≤ 5 x ULN and/or alkaline phosphatase ≤ 5 x ULN: Patients who do notconform to the transaminase and/or alkaline phosphatase inclusion criteria, but who bythe PI are considered in good PS and otherwise eligible for inclusion, and where thetransaminase and/or alkaline phosphatase levels are considered elevated due to otherreasons than deteriorated lever capacity, may be considered for inclusion based onconferred agreement between PI and sponsor.

Exclusion Criteria: Patients meeting any of the following criteria will be excluded from enrollment:

1. Concurrent chemotherapy, radiotherapy, or other investigational drug during studyperiod.
2. Previous surgeries with resection of the complete stomach or greater part of smallintestines (excluding the duodenum), whereby absorption of SCO-101 may be affected.Treatment with Creon or similar is allowed.
3. Difficulty in swallowing tablets.
4. CNS metastases requiring steroids.
5. Treatment with antibiotics for infections or with clinical symptoms of activeinfection. Patients showing symptoms of CoViD19 must be tested for active CoViD19infection.
6. Known HIV positivity.
7. Known active hepatitis B or C.
8. Clinically significant (i.e. active) cardiovascular disease:

• Stroke, Transient ischemic attack (TIA) or myocardial infarction within ≤ 6months prior to day 1.
• Unstable angina or NYHA Grade II or greater congestive heart failure (CHF).
• Serious cardiac arrhythmia requiring medication.

9. Mental status, symptomatic epilepsy or other CNS disease where the investigatorassesses the patient not fit for the clinical study.
10. Other medications or conditions that in the Investigator's opinion wouldcontraindicate study participation of safety reasons or interfere with theinterpretation of study results. Other severe medical conditions, including seriousheart disease, unstable diabetes, uncontrolled hypercalcemia or previous organtransplants. Participation in another clinical trial with experimental medicationwithin 30 days prior to registration.
11. Known hypersensitivity to gemcitabine and/or nab-paclitaxel.
12. Pregnant women or women who are breastfeeding.
13. Prior or present neuropathy > grade I (NCI-CTCAE v.5.0).
14. Curatively intended treatment.