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| ID | Type | Description | Link |
|---|---|---|---|
| STUDY00001055 | Other Identifier | University of Texas Health Science Center at San Antonio IRB |
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| Name | Class |
|---|---|
| BeiGene | INDUSTRY |
| Syntrix Biosystems, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the safety and clinical activity of tislelizumab (an anti-PD-1 antibody) in combination with SX-682 (a CXCR1/2 inhibitor) in subjects with newly diagnosed and surgically resectable pancreatic adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Tislelizumab and SX-682 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Patients will receive Tislelizumab (200 mg intravenous) on Day 1 of Cycles 1-6. Cycle 1 will be 14 days long and occur prior to surgery. Cycle 2 will be 14 days long and occur prior to standard of care chemotherapy. Cycles 3-6 will each be 21 days long and will be given after completion of standard of care chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Immune response rate as assessed by density of intratumoral granzyme B+ CD137+ T cells | The change in density of intratumoral granzyme B+ CD137+ T cells before and after neoadjuvant treatment with tislelizumab and SX-682. | Baseline and 2 weeks |
| Pathologic Response Rate as assessed by number of patients with a grade 0-2 pathologic response | The number of patients with a grade 0-2 pathologic response as defined by the College of American Pathologists (CAP) tumor regression grading system. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing grade 3 or above drug-related toxicities | When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject. | 4 years |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lei Zheng, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins SKCCC | Baltimore | Maryland | 21231 | United States | ||
| The University of Texas Health Science Center San Antonio |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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| SX-682 | Drug | Patients will receive SX-682 (200 mg twice daily by mouth) on Days 1-14 of Cycles 1-2 and Days 1-21 of Cycles 3-6. Cycle 1 will be 14 days long and occur prior to surgery. Cycle 2 will be 14 days long and occur prior to standard of care chemotherapy. Cycles 3-6 will each be 21 days long and will be given after completion of standard of care chemotherapy. |
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OS is defined as the time from the first dose of study treatment to death from any cause. Patients who have not died will be censored at the last date known to be alive. Estimation based on the Kaplan-Meier curve.
| 4 years |
| Disease Free Survival (DFS) | DFS is defined as the time from the first dose of study treatment until evidence of disease recurrence or death from any cause. For patients who have not progressed, relapsed, or died at the time of analysis, DFS will be censored on the date of last visit where disease progression was evaluable. Estimation based on the Kaplan-Meier curve. | 4 years |
| San Antonio |
| Texas |
| 78229 |
| United States |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |