Actively Recruiting
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
Led by University of Rochester · Updated on 2025-06-05
20
Participants Needed
1
Research Sites
318 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
S
Syntrix Biosystems, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged at least 18 years
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
- Completed at least 16 weeks of first line chemotherapy without disease progression
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- At least 1 measurable lesion per iRECIST
- Screening labs within 14 days before first dose meeting specific blood count and liver function criteria
- Life expectancy of at least 12 weeks
- Consent for baseline and on-treatment biopsies
- Baseline pulse oximetry of at least 90% on room air
- Ability and willingness to comply with study visits, treatment schedule, tests, and biopsies
- Signed informed consent and HIPAA authorization obtained before study procedures
You will not qualify if you...
- Active brain or leptomeningeal metastases unless treated and stable for at least 8 weeks with no recent progression
- Need for high dose systemic corticosteroids (>10 mg/day prednisone equivalents) within 2 weeks before study drug
- Active, non-infectious pneumonitis or interstitial lung disease requiring steroids
- Clinically significant heart or cardiovascular disease affecting normal activities
- Recent serious cardiovascular events within 6 months (e.g., stroke, myocardial infarction)
- Prior malignancy active within 3 years except certain cured cancers
- Active, known or suspected autoimmune disease except certain controlled conditions
- Use of systemic immunosuppressive treatments above specified doses
- Use of investigational drugs or immunotherapy within specified recent time frames
- Major surgery within 4 weeks before enrollment (except diagnostic laparoscopy)
- History of myelodysplastic syndromes or myeloproliferative neoplasms
- History or medication-induced prolonged QT interval
- Use of botanical or herbal preparations for cancer treatment
- History of hepatitis B or C infection
- Known HIV/AIDS infection
- Active tuberculosis
- QTc interval >470 msec or congenital long QT syndrome
- Allergies or severe reactions to study drug components or monoclonal antibodies
- History of anaphylaxis or recent uncontrolled asthma
- Women of childbearing potential not using effective contraception or breastfeeding
- Men sexually active with women of childbearing potential not using effective contraception
- Vulnerable populations such as incarcerated or detained individuals
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
C
Chris LeFeber
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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