An Open-label Phase 1 Study to Evaluate the Safety and Tolerability of SX-682 in Combination With Nivolumab as a Maintenance Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
The main purpose of this research study is to determine the maximum tolerable dose (MTD) of SX-682 in combination with nivolumab in patients with metastatic pancreatic ductal adenocarcinoma who have completed at least 16 weeks of first line chemotherapy treatment without evidence of disease progression.
‣ Written Informed Consent and HIPAA Authorization
• Subjects must have the nature of the study explained to them
• Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, pharmacokinetic collections, study biopsies and other requirements of the study.
• Subjects (or an acceptable proxy) must provide a signed and dated IRB/IEC approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines for both the study and exploratory biomarker analysis obtained via paired biopsies.
• Subjects (or an acceptable proxy) must provide a signed and dated Health Insurance Portability and Accountability Act (HIPAA) authorization.
• The ICF and HIPAA authorization must be obtained before conduction and procedures that do not form a part of the subject's normal care.
• After signing the ICF and HIPAA Authorization, subjects will be evaluated for study eligibility during the Screening Period (no more than 28 days before study drug administration) according to the following further inclusion/exclusion criteria:
‣ Study Population/Inclusion Criteria
• Male or female subjects, aged at least 18 years
• Have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
• Completion of at least 16 weeks of first line chemotherapy without evidence of disease progression
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Must have measurable disease with at least 1 unidimensional measurable lesion per iRECIST
• Screening laboratory values within 14 days prior to first dose of study drug:
• WBC ≥ 3000/µL Neutrophils ≥ 1500/µL Platelets ≥ 100,000\>µL Hemoglobin ≥ 9.0 g/dL in the absence of blood transfusion Creatinine ≤ 1.5 mg/dL AST/ALT ≤ 2.5 x ULN for subjects with no liver metastases
⁃ 5 x ULN for subjects with liver metastases Bilirubin ≤ 1.5 mg/dL sa≤ 3.0 mg/dL for subjects with Gilbert's disease INR or PT ≤ 1.5 x ULN unless receiving anticoagulation therapy aPTT or PTT ≤ 1.5 x ULN unless receiving anticoagulation therapy
• Life expectancy of ≥ 12 weeks as judged by the treating physician.
• Patient must consent for baseline and on treatment biopsies
• Patients must have baseline pulse oximetry ≥ 90% on room air