Clinical Trials /

Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients

NCT04536077

Description:

The central hypothesis is that the addition of CDX-301 to CDX-1140 radically improves anti-tumor immunity in patients with pancreatic ductal adenocarcinoma.

Related Conditions:
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients
  • Official Title: Testing the Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients

Clinical Trial IDs

  • ORG STUDY ID: 20-x303
  • NCT ID: NCT04536077

Conditions

  • Pancreatic Cancer
  • Cancer of the Pancreas
  • Pancreas Cancer

Interventions

DrugSynonymsArms
CDX-301CDX-1140 + CDX-301
CDX-1140CDX-1140 + CDX-301

Purpose

The central hypothesis is that the addition of CDX-301 to CDX-1140 radically improves anti-tumor immunity in patients with pancreatic ductal adenocarcinoma.

Trial Arms

NameTypeDescriptionInterventions
CDX-1140 MonotherapyExperimentalPatients randomized to the CDX-1140 monotherapy arm will receive a single IV infusion at a dose of 1.5 mg/kg, with surgery to follow 7-12 days after administration of CDX-1140.
  • CDX-1140
CDX-1140 + CDX-301ExperimentalPatients randomized to the CDX-301 + CDX-1140 arm will receive CDX-301 at 75 mcg/kg/day as a subcutaneous injection every day for 5 days (Days 1-5) with CDX-1140 IV at 1.5 mg/kg on Day 8 +/-1 day. Surgery will be 7-12 days after administration of CDX-1140.
  • CDX-301
  • CDX-1140

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed surgically resectable pancreatic ductal
             adenocarcinoma, but not adenosquamous/squamous pancreas cancers (as determined by
             operating surgeon or tumor board).

          -  At least 18 years of age.

          -  ECOG performance status ≤ 1

          -  Normal bone marrow and organ function as defined below:

               -  Absolute neutrophil count ≥ 1,500 /cumm

               -  Platelets ≥ 100,000 /cumm

               -  Hemoglobin ≥ 9.0 g/dL

               -  AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN

               -  Creatinine clearance ≤ 1.5 x IULN or glomerular filtration rate of ≥ 60 mL/min

               -  INR ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR
                  or PTT is within therapeutic range of intended use of anticoagulants

               -  aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as
                  INR or PTT is within therapeutic range of intended use of anticoagulants

               -  Albumin ≥ 3.0mg/dL

          -  The effects of CDX-301 and CDX-1140 on the developing human fetus are unknown. For
             this reason, women of childbearing potential and men must agree to use adequate
             contraception (hormonal or barrier method of birth control, abstinence) prior to study
             entry, for the duration of study participation, and for 3 months after the last dose
             of either study drug. Should a woman become pregnant or suspect she is pregnant while
             participating in this study or for 3 months after the last dose of either study drug,
             she must inform her treating physician immediately.

          -  Ability to understand and willingness to sign an IRB approved written informed consent
             document (or that of legally authorized representative, if applicable).

        Exclusion Criteria:

          -  Immune deficiencies such as HIV.

          -  A history of other malignancy with the exception of malignancies for which all
             treatment was completed at least 2 years before registration and the patient has no
             evidence of disease.

          -  Currently receiving any other investigational agents or has received any other
             investigational agents within 4 weeks or 5 half-lives of the planned first dose of
             study treatment.

          -  A history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to CDX-301 or CDX-1140 or other agents used in the study.

          -  Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
             (for > 1 month of 10 mg prednisone daily, or equivalent) or any other form of
             immunosuppressive therapy not routinely associated with chemotherapeutic regimen.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, immunosuppression, autoimmune conditions, or underlying pulmonary disease.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, immunosuppression, autoimmune conditions, or underlying pulmonary disease.

          -  Has an autoimmune disease requiring systemic treatment within the past 2 years (i.e.
             with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
             Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
             form of systemic treatment.

          -  Known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)
             or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected).

          -  Has a history of (non-infectious) pneumonitis that required steroids or current
             pneumonitis.

          -  Has a known history of active TB (bacillus tuberculosis).

          -  Major surgery within 28 days prior to the first study treatment.

          -  Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
             pregnancy test within 14 days of study entry.

          -  History of bone marrow or solid organ transplant.

          -  Patients with a history of myocardial infarction, cerebral vascular accident,
             thrombosis or pulmonary embolus within 12 months prior to the first dose of study
             treatment are excluded from this study.

          -  Patients with known mutations/amplifications in Flt3
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Amount of intratumoral conventional dendritic cells between patients treated with CDX-1140 alone versus patients treated with CDX-301 plus CDX-1140
Time Frame:At time of surgery (estimated to be between day 8 and day 20)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Washington University School of Medicine

Last Updated

August 27, 2020