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

NCT04477343 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: UGIP20027
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Keywords

Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerable dose [Safety and Tolerability]

  Maximum tolerable dose is defined by less than or equal to 30% dose limiting toxicity (DLT) event rate within a given dose combination,

  through study completion, an average of 6 months

Secondary Outcomes (2)

• 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

• Overall Survival

  From date of enrollment until date of death from any cause up to 24 months

Study Arms (1)

Experimental: SX-682 and Nivolumab

EXPERIMENTAL

SX-682 Dose: 25, 50, 100, 200, 400mg BID taken as an oral pill Nivolumab Dose: 240mg, every 2 weeks via intravenous infusion

Drug: SX-682; Drug: Nivolumab Injectable Product

Interventions

SX-682 DRUG

Allosteric inhibitor to human CXCR1 and CXCR2 receptor

Experimental: SX-682 and Nivolumab

Nivolumab Injectable Product DRUG

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

Experimental: SX-682 and Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• Target Disease Exceptions:
• Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI- except where contraindicated, in which case a CT scan is acceptable) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. An MRI is not required to rule out brain metastases or leptomeningeal metastases. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (\>10 mg/day prednisone equivalents) for at least 2 weeks prior to study dry administration.
• Medical History and Concurrent Disease
• Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results. Specifically:

Sponsors & Collaborators

• University of Rochester: lead
• Syntrix Biosystems, Inc.: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Daniel Mulkerin, MD

  University of Rochester Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris LeFeber

CONTACT

585-275-0407; Chris_LeFeber@URMC.Rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Department of Medicine , Hematology/Oncology

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 20, 2020
• Study Start: November 23, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (1)