RecruitingPhase 1NCT04477343

A 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

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


Sponsor

University of Rochester

Enrollment

20 participants

Start Date

Nov 23, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — SX-682 (which blocks signals that help tumors hide from the immune system) and nivolumab (an immunotherapy drug) — as maintenance therapy for patients with advanced pancreatic cancer who have already responded to initial chemotherapy. **You may be eligible if...** - You have been diagnosed with metastatic pancreatic ductal adenocarcinoma (a type of advanced pancreatic cancer) - You have already received initial chemotherapy and have stable or responding disease - You are willing to undergo tumor biopsies and regular study visits - You are 18 or older **You may NOT be eligible if...** - Your cancer has progressed through prior treatment - You have significant organ problems that would make treatment unsafe - You are pregnant or breastfeeding - You have active autoimmune disease or are on high-dose steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSX-682

Allosteric inhibitor to human CXCR1 and CXCR2 receptor

DRUGNivolumab Injectable Product

humanized monoclonal antibody to program cell death receptor 1 (PD1)


Locations(1)

University of Rochester

Rochester, New York, United States

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NCT04477343


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