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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04440943
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics

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

Condition or disease Intervention/treatment Phase
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 Drug: CDX-527 Phase 1

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 40 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
Actual Study Start Date : August 4, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : January 2023


Arm Intervention/treatment
Experimental: CDX-527

Dose-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.

Drug: CDX-527
CDX-527 is administered by infusion every 2 weeks




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


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years. ]
    The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)

  2. Clinical Benefit Rate [ Time Frame: Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years. ]
    The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months

  3. Duration of Response [ Time Frame: First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years) ]
    The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented

  4. 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) ]
    The time from start of study drug to time of progression or death, whichever occurs first

  5. Overall Survival [ Time Frame: The time from start of study drug to death from any cause (up to approximately 1-2 years) ]
    The time from start of study drug to death

  6. 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 ]
    Serum samples will be obtained for assessment of human anti-CDX-527 antibodies

  7. 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 ]
    CDX-527 serum concentrations will be measured at specified visits.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440943


Contacts
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Contact: Celldex Therapeutics (844) 723-9363 info@celldex.com

Locations
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United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Anila Lokhandwala    404-236-8124      
Principal Investigator: Rodolfo Bordoni, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jose Torio       jtorio@medicine.bsd.uchicago.edu   
Principal Investigator: Gini Fleming, MD         
United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Duke Center for Cancer Immunotherapy Clinical Trials Office    919-681-6468    CCI-ImmunoOnc@duke.edu   
Principal Investigator: Mustafa Khasraw, MD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Christina Lopez    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Rachel Sanborn, MD         
Sponsors and Collaborators
Celldex Therapeutics
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Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT04440943    
Other Study ID Numbers: CDX527-01
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Fallopian Tube Neoplasms
Cholangiocarcinoma
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Fallopian Tube Diseases
Liver Diseases