Can a pill rouse the immune system against pancreatic cancer?
NCT ID NCT04123574
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether an experimental oral drug called BXCL701 can change how the immune system responds to pancreatic cancer. The study will enroll people with untreated, locally advanced or metastatic pancreatic cancer who can undergo tumor biopsies before and after treatment. Researchers will measure immune markers in the blood and tumor, and check whether the drug affects tumor growth or cell death. The goal is to see if this approach is worth studying further.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- talabostat mesylate (BXCL701), an oral drug that inhibits dipeptidyl peptidases to modulate the immune system
- What this could lead to
- If it works, this could point toward a new way to treat pancreatic cancer by harnessing the immune system.
- What could go wrong
- This is a very early, small pilot study, so it may not show clear benefit or may have side effects. The results may not lead to a larger trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Expected to start
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Oct 2019
An estimate. Start dates often move.
- Expected to finish
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Dec 2021
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Has untreated (eg, no prior investigational therapies, chemotherapy, or radiation therapy), locally advanced or metastatic adenocarcinoma of the head, neck, uncinate process, or tail of the pancreas with a local or metastatic lesion that is amenable to biopsy before and after treatment. (Whenever possible, the before and after treatment biopsies should be from the same lesion.) 2. Is able and willing to undergo tumor biopsy before and after treatment. (A pretreatment biopsy may not be needed if tissue is available from a biopsy conducted within 28 days prior to screening that is adequate for the study assessments.) 3. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 4. Is 18 to 75 years of age, inclusive 5. Has adequate organ function within 28 days of treatment initiation 6. For participants with exposure to prior agents associated with decreased left ventricular ejection fraction (LVEF) (e.g. anthracyclines), or if clinically warranted, a documented LVEF \> 45% using a standard echocardiogram (ECHO) or multigated acquisition (MUGA) scan test at Screening or within 60 days prior to Cycle 1 Day 1. ECHO or MUGA testing for other participants without relevant medical history or clinical symptoms can be performed if feasible. 7. Has oxygen saturation ≥ 92% on room air. 8. Is able to take an oral medication. 9. Has signed an Informed Consent Form (ICF) prior to the initiation of any study-specific procedures or treatment. 10. Is willing and able to adhere to the study visit schedule and other protocol requirements. 11. Women of childbearing potential (WOCBP) must have a negative pregnancy test at baseline. A woman must be menopausal for at least 12 months before she is considered not to be of reproductive potential. 12. Male and female patients of reproductive potential must agree to use an effective contraceptive method during participation in this study and for 6 months following the study. Exclusion Criteria: 1. A female who is pregnant or breast-feeding. 2. Has other concurrent malignancies except for basal and squamous cell cancers of the skin and in-situ cervical cancer. 3. Has uncontrolled epilepsy, central nervous system diseases, or a history of mental disorder that is severe enough to hinder the ability of the patient to provide informed consent or that may influence the patient's compliance with the protocol in the judgments of the investigator. 4. Has an upper gastrointestinal obstruction, abnormal physiological function, or malabsorption syndrome that may affect the absorption of study medication. 5. Has required chronic corticosteroids, defined as \> 10 mg/day of prednisone or equivalent, or immunosuppressive therapy within the past 3 months. Patient requires treatment with DPP4 inhibitors (e.g. gliptins). 6. Has a premalignant hematologic disorder, eg, myelodysplastic syndrome. 7. Has a severe organ dysfunction or disease that might prevent completion of the treatment regimen, eg, cardiopulmonary diseases (New York Heart Association \[NYHA\] ≥ Class III, arrhythmia Lown III/IV, global respiratory insufficiency); ascites; acute pancreatitis; bleeding diathesis, coagulopathy, or need for full dose anticoagulation. 8. Has a chronic infectious disease, especially immune deficiency syndromes, eg, human immunodeficiency virus (HIV) infection, active tuberculosis within 12 months prior to potential study participation or suspected/active SARS-CoV-2 (Covid-19) infection. 9. Has a history of severe neurologic disorders, eg, cerebrovascular ischemia within the past year. 10. Has a history of prior deep venous thrombosis or pulmonary embolism within the past year. 11. Has serious medical, psychological, familial, sociological, or geographical conditions or circumstances potentially hampering compliance with the study protocol and follow-up. 12. QT interval corrected for heart rate using Bazett's formula (QTcB) \> 440 msec at Screening. 13. Patients with history of symptomatic orthostatic hypotension within 3 months prior to enrollment. Orthostatic hypotension is defined as a drop in systolic blood pressure (BP) of ≥ 20 mmHg or diastolic BP of ≥ 10 mmHg with assumption of an upright posture
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BioXcel Clinical Research Site
Boston, Massachusetts, 02215, United States
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BioXcel Clinical Research Site
New York, New York, 10021, United States
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