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

• Status: Recruiting
• Trial end date: 2022-05-15
• Target enrollment: 0
• Participant gender: All

Summary

An open-label dose escalating phase Ib study of SCO-101 in combination with gemcitabine and nab-paclitaxel. The primary objectives are to establish the safety profile and the MTD of SCO-101 when combined with gemcitabine and nab-paclitaxel. The starting dose of SCO-101 is 150 mg and the dose may be increased to a maximum of 350 mg.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scandion Oncology A/S
• Collaborator: Alcedis GmbH
• Treatments: Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• 1. Ability to understand and willingness to provide written informed consent before any trial-related activities.

2. Age 18 years or older.

3. Histologically verified pancreatic adenocarcinoma.

4. Inoperable localized, locally advanced or metastatic pancreatic cancer, not amenable for curatively intended treatment, in patients who are to be treated with gemcitabine and 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 prior radiotherapy 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 10^9/L

• Hemoglobin is at least 6,0 mmol/L

• Platelets ≥ 100 x 10^9/L

• Alanine aminotransferase (ALT) 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 highly effective contraception (intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) for the study duration and at least 6 months after the last dose of study drug

12. Signed informed consent.

Exclusion Criteria:

• 1. Concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.

2. Previous surgeries with resection of the complete stomach or greater part of small intestines (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 active infection. Patients showing symptoms of CoViD19 must be tested for active CoViD19 infection.

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 ≤ 6 months 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 investigator assess the patient not fit for the clinical study.

10. Other medications or conditions that in the Investigator's opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results. Other severe medical conditions, including serious heart disease, unstable diabetes, uncontrolled hypercalcemia or previous organ transplants. Participation in another clinical trial with experimental medication within 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.