Clinical Trials /

A Pilot Study of BXCL701 in Patients With Pancreatic Cancer

NCT04123574

Description:

A study to assess the biochemical and immunomodulatory effects of BXCL701 in pancreatic cancer.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Pilot Study of BXCL701 in Patients With Pancreatic Cancer
  • Official Title: A Pilot Proof of Mechanism Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPPs), in Patients With Pancreatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: BXCL701-001
  • NCT ID: NCT04123574

Conditions

  • Cancer of Pancreas
  • Cancer of the Pancreas
  • Neoplasms, Pancreatic
  • Pancreas Cancer
  • Pancreatic Cancer

Interventions

DrugSynonymsArms
Talabostat MesylateBXCL701Single Arm

Purpose

A study to assess the biochemical and immunomodulatory effects of BXCL701 in pancreatic cancer.

Detailed Description

      This is a Phase 0 or "window of opportunity" study where paired specimen analysis, taken
      before and after drug exposure, will permit the evaluation of target modulation and
      assessment of immune effector cell infiltration into the tumor and the generation of relevant
      immune cytokines.

      In this study, BXCL701 will be administered at a dose of 0.6 mg, once daily (the previously
      defined maximum tolerated dose [MTD] of the drug), to all patients for a short period of 14
      days. This study is designed to assess the biochemical and immunomodulatory effects of
      BXCL701 in pancreatic cancer.
    

Trial Arms

NameTypeDescriptionInterventions
Single ArmExperimentalBXCL701 will be administered at a dose of 0.6 mg, once daily to all patients for a short period of 14 days
  • Talabostat Mesylate

Eligibility Criteria

        Inclusion Criteria:

          -  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.)

          -  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.)

          -  Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

          -  Is 18 to 75 years of age, inclusive

          -  Has adequate organ function within 28 days of treatment initiation

          -  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.

          -  Has oxygen saturation ≥ 92% on room air.

          -  Is able to take an oral medication.

          -  Has signed an Informed Consent Form (ICF) prior to the initiation of any
             study-specific procedures or treatment.

          -  Is willing and able to adhere to the study visit schedule and other protocol
             requirements.

          -  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.

          -  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:

          -  A female who is pregnant or breast-feeding.

          -  Has other concurrent malignancies except for basal and squamous cell cancers of the
             skin and in-situ cervical cancer.

          -  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.

          -  Has an upper gastrointestinal obstruction, abnormal physiological function, or
             malabsorption syndrome that may affect the absorption of study medication.

          -  Has required chronic corticosteroids, defined as > 10 mg/day of prednisone or
             equivalent, or immunosuppressive therapy within the past 3 months.

          -  Has a premalignant hematologic disorder, eg, myelodysplastic syndrome.

          -  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.

          -  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.

          -  Has a history of severe neurologic disorders, eg, cerebrovascular ischemia within the
             past year.

          -  Has a history of prior deep venous thrombosis or pulmonary embolism within the past
             year.

          -  Has serious medical, psychological, familial, sociological, or geographical conditions
             or circumstances potentially hampering compliance with the study protocol and
             follow-up.

          -  QT interval corrected for heart rate using Bazett's formula (QTcB) > 440 msec at
             Screening.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To characterize the quantitative and qualitative effects of BXCL701 on relevant immune effector cytokines and various immunological effector cells that are consistent with its known mechanism of action.
Time Frame:Up to 37 days post treatment
Safety Issue:
Description:To measure how BXCL701 effects the tumor by measuring the rate of tumor cell death or the reduction of tumor cell growth. This will be measured by scans and blood work.

Secondary Outcome Measures

Measure:Evaluate the tolerability of exposure to BXCL701: National Cancer Institute Common Terminology Criteria
Time Frame:Up to 37 days post treatment
Safety Issue:
Description:assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events
Measure:Evaluate the effect of exposure to BCXL701 on cancer cell death
Time Frame:Up to 37days post treatment
Safety Issue:
Description:Measure the rate of cancer cell death measured by histological staining methods of post-treatment biopsied tissue.
Measure:Genomic analysis before and after treatment.
Time Frame:Up to 37 days post treatment
Safety Issue:
Description:Genomic analysis is the identification, measurement or comparison of genomic features such as DNA sequence, structural variation, gene expression, or regulatory and functional element annotation at a genomic scale.

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BioXcel Therapeutics Inc

Trial Keywords

  • Pancreas
  • Cancer
  • Neoplasms
  • Pancreatic

Last Updated

November 13, 2019