Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer
Brief summary
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.
Detailed description
In this study the investigator would like to better understand 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. In addition, the investigator would like to measure the SX-682 pharmacokinetic data in humans. The investigator would also like to assess the immunophenotypic and stromal changes to the tumor microenvironment after treatment.
Interventions
DRUGSX-682
Allosteric inhibitor to human CXCR1 and CXCR2 receptor
humanized monoclonal antibody to program cell death receptor 1 (PD1)
Sponsors
University of Rochester
Syntrix Biosystems, Inc.
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Written Informed Consent and HIPAA Authorization 1. Subjects must have the nature of the study explained to them 2. 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. 3. 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. 4. Subjects (or an acceptable proxy) must provide a signed and dated Health Insurance Portability and Accountability Act (HIPAA) authorization. 5. The ICF and HIPAA authorization must be obtained before conduction and procedures that do not form a part of the subject's normal care. 6. 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 1. Male or female subjects, aged at least 18 years 2. Have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma 3. Completion of at least 16 weeks of first line chemotherapy without evidence of disease progression 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 5. Must have measurable disease with at least 1 unidimensional measurable lesion per iRECIST 6. 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 7. Life expectancy of ≥ 12 weeks as judged by the treating physician. 8. Patient must consent for baseline and on treatment biopsies 9. Patients must have baseline pulse oximetry ≥ 90% on room air
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerable dose [Safety and Tolerability] | through study completion, an average of 6 months | Maximum tolerable dose is defined by less than or equal to 30% dose limiting toxicity (DLT) event rate within a given dose combination, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | Measure of time from study enrollment until progression. |
| Overall Survival | From date of enrollment until date of death from any cause up to 24 months | Measure of time from study enrollment until death from any cause. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel Mulkerin, MD
University of Rochester Wilmot Cancer Center
Outcome results
None listed