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Pancreatic Ductal AdenocarcinomaPhase 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

A Phase 1 study testing SX-682 and Nivolumab Injectable Product in people with Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer, run by University of Rochester at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SX-682 and Nivolumab Injectable Product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
23 Nov 2020to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • After signing the ICF and HIPAA Authorization, subjects will be evaluated for study eligibility during the Screening Period (no more than 28 days before study drug administration) according to the following further inclusion/exclusion criteria:
  • Study Population/Inclusion Criteria
  • 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
  • 5 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

Who cannot join

  • 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:
  • Subjects with active, non-infectious pneumonitis.
  • Subjects with interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
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  • Subjects with clinically significant heart disease that affects normal activities.
  • Clinically significant cardiovascular/ cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attach (< 6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >II) or serious cardiac arrhythmia.
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.
  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Subjects with a condition (including organ or bone marrow transplant) requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Use of other investigational drugs (drugs not marketed for any indication) or medications at immunosuppressive doses within 28 days before study drug administration.
  • Patients who received immunotherapy or investigational drug within 4 weeks prior to enrollment.
  • Patients who underwent major surgery within 4 weeks of enrollment (not including diagnostic laparoscopy)
  • History of myelodysplastic syndromes or myeloproliferative neoplasms.
  • History of or medication induced prolonged QT interval.
  • Any botanical preparation (e.g., herbal supplements or traditional Chinese medicines) intended to treat the disease under study or provide supportive care. Use of marijuana and its derivatives for treatment of symptoms related to cancer treatment, even if obtained by medical prescription or if its use (even without a medical prescription) has been legalized locally.
  • Physical and Laboratory Test Findings
  • A history of Hepatitis B or C, either acute or chronic, as indicated by HBV surface antigen positivity, HBV core antibody positivity, or positive HCV antibody with reflex to positive HCV RNA.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Active tuberculosis (history of exposure or history of positive tuberculosis test plus presence of clinical symptoms, physical or radiographic findings).
  • EKG demonstrating a QTc interval >470 msec or patients with congenital long QT syndrome.
  • Allergies and Adverse Drug Reaction
  • History of allergy to study drug components (examples: hydroxpropylmethylcellulose phthalate (hypromellose phthalate or HPMCP), microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, and silicon dioxide).
  • History of severe hypersensitivity reaction to any monoclonal antibody (Grade ≥ 3 NCI-CTCAE v5).
  • History of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma.
  • Sex and Reproductive Status/Special Populations
  • Women of childbearing potential (WOCBP) must use method(s) of contraception with a failure rate of less than 1% while on study and for 5 months after the last dose of SX-682 or nivolumab. A WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over age 45 in the absence of other biological or physiological causes.
  • Women under the age of 62 with a history of being postmenopausal must have a documented serum follicle stimulating hormone, (FSH) level > 40 mIU/mL.
  • Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
  • Women must not be breastfeeding.
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year while on study and for a period at least 7 months after the last dose of study drug.
  • Women who are not of childbearing potential and azoospermic men do not require contraception.
  • Individuals who are incarcerated, compulsory detained or otherwise considered a vulnerable population

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

In this study the investigator would like to better understand 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. In addition, the investigator would like to measure the SX-682 pharmacokinetic data in humans. The investigator would also like to assess the immunophenotypic and stromal changes to the tumor microenvironment after treatment.

Being tested
SX-682, Nivolumab Injectable Product
Keywords
Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SX-682Drug

    Allosteric inhibitor to human CXCR1 and CXCR2 receptor

  • Nivolumab Injectable ProductDrug

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

Study groups in NCT04477343
Study groupRoleWhat they receive
Experimental: SX-682 and NivolumabExperimentalSX-682 Dose: 25, 50, 100, 200, 400mg BID taken as an oral pill Nivolumab Dose: 240mg, every 2 weeks via intravenous infusion
Receives: Drug: SX-682; Drug: Nivolumab Injectable Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  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,

    Measured: through study completion, an average of 6 months

Secondary outcomes (2)

  1. Progression Free Survival

    Measure of time from study enrollment until progression.

    Measured: 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

  2. Overall Survival

    Measure of time from study enrollment until death from any cause.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start23 Nov 2020
  3. Primary completion6 May 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04477343
Sponsor's protocol ID
UGIP20027
Status last verified
Jul 2026
First submitted
10 Jul 2020
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SX-682 and Nivolumab Injectable Product in people with Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerable dose [Safety and Tolerability] (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04477343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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