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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT04477343
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SX-682 — DRUG
    Allosteric inhibitor to human CXCR1 and CXCR2 receptor
  • Nivolumab Injectable Product — DRUG
    humanized monoclonal antibody to program cell death receptor 1 (PD1)

Study Details

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.

Key Dates

Start date
Nov 23, 2020
Status verified
Jun 2025
Primary completion
Jun 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Maximum tolerable dose [Safety and Tolerability] [ Time Frame: through study completion, an average of 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642
Chris LeFeber
[email protected]
585-275-0407
Daniel Mulkerin (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, NY

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Rochester· Rochester, NY

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