Clinical Trials /

A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

NCT04440943

Description:

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

Related Conditions:
  • Colorectal Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
  • Official Title: A Phase 1 Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

Clinical Trial IDs

  • ORG STUDY ID: CDX527-01
  • NCT ID: NCT04440943

Conditions

  • Non-small Cell Lung Cancer
  • Breast Cancer
  • Gastric Cancer
  • Renal Cell Carcinoma
  • Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Fallopian Tube Cancer
  • Cholangiocarcinoma
  • Bladder Urothelial Carcinoma
  • MSI-H Colorectal Cancer
  • Esophageal Cancer
  • Hepatic Cancer
  • Head and Neck Cancer
  • Other Solid Tumors

Interventions

DrugSynonymsArms
CDX-527CDX-527

Purpose

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

Detailed Description

      This study will determine the safety, tolerability and activity of CDX-527.

      Eligible patients that enroll to the dose-escalation portion of the study will be assigned to
      one of several dose levels of CDX-527. The dose-escalation part of the study will determine
      the safety profile of CDX-527 and determine which dose(s) of CDX-527 will be studied in the
      expansion part of the study.

      The expansion part of the study will enroll eligible patients with certain solid tumors to be
      treated at dose(s) identified during dose-escalation

      Up to 96 patients will be enrolled. All patients enrolled in the study will be closely
      monitored to determine if there is a response to the treatment as well as for any side
      effects that may occur.
    

Trial Arms

NameTypeDescriptionInterventions
CDX-527ExperimentalDose-escalation phase: Eligible patients will receive CDX-527 treatment based on cohort assigned until progression or intolerance. Expansion phase: Patients will receive CDX-527 at the dose level(s) chosen during the escalation phase.
  • CDX-527

Eligibility Criteria

        Key Inclusion Criteria:

          1. Recurrent, locally advanced or metastatic solid tumor cancer excluding the following:
             MSI-low colorectal cancer, glioblastoma multiforme, prostate cancer, pancreatic
             cancer, mucosal and ocular melanoma.

          2. Receipt of all standard therapies for the tumor type

          3. Measurable (target) disease by iRECIST

          4. If of childbearing potential (male or female), agrees to practice an effective form of
             contraception during study treatment and for at least 3 months following last
             treatment

          5. Willingness to undergo a pre-treatment and on-treatment biopsy, if required

        Key Exclusion Criteria:

          1. History of severe hypersensitivity reactions to other monoclonal antibodies.

          2. Previous treatment with any anti-CD27 antibody.

          3. Inadequate washout period from prior therapy as defined in the Protocol.

          4. Patients who have received more than 0 or 1 prior PD-1/PD-L1 inhibitor depending on
             their tumor type

          5. Major surgery within 4 weeks prior to study treatment.

          6. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within
             2 weeks prior to study treatment.

          7. Other prior malignancy, except for adequately treated basal or squamous cell skin
             cancer or in situ cancers. For all other cancers, the patient must be disease-free for
             at least 3 years to be allowed to enroll.

          8. Thrombotic events within the last 6 months prior to study treatment

          9. Active, untreated central nervous system metastases.

         10. Active autoimmune disease or documented history of autoimmune disease.

         11. History of (non-infectious) pneumonitis or has current pneumonitis.

         12. Active diverticulitis

         13. Known infection of HIV, Hepatitis B, or Hepatitis C.

        There are additional criteria your study doctor will review with you to confirm your
        eligibility for the study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0
Time Frame:From first dose through 28 days after last dose
Safety Issue:
Description:The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.

Secondary Outcome Measures

Measure:Objective Response Rate
Time Frame:Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years.
Safety Issue:
Description:The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)
Measure:Clinical Benefit Rate
Time Frame:Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years.
Safety Issue:
Description:The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months
Measure:Duration of Response
Time Frame:First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years)
Safety Issue:
Description:The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented
Measure:Progression-free Survival
Time Frame:From the first dose to the first occurrence of disease progression or death due to any cause (up to approximately 1-2 years)
Safety Issue:
Description:The time from start of study drug to time of progression or death, whichever occurs first
Measure:Overall Survival
Time Frame:The time from start of study drug to death from any cause (up to approximately 1-2 years)
Safety Issue:
Description:The time from start of study drug to death
Measure:Immunogenicity Evaluation
Time Frame:Prior to the first dose of study treatment, then intermittently before dosing, and up to 60 days after the last dose
Safety Issue:
Description:Serum samples will be obtained for assessment of human anti-CDX-527 antibodies
Measure:Pharmacokinetic Evaluation
Time Frame:Before and after dosing, with additional timepoints after the first two doses, then intermittently before dosing and up to 60 days after the last dose
Safety Issue:
Description:CDX-527 serum concentrations will be measured at specified visits.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Celldex Therapeutics

Last Updated

June 18, 2020