Status:
COMPLETED
A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
Lead Sponsor:
Celldex Therapeutics
Conditions:
Non-small Cell Lung Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Key
- 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.
- Receipt of all standard therapies for the tumor type
- Measurable (target) disease by iRECIST
- 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
- Willingness to undergo a pre-treatment and on-treatment biopsy, if required
- Key
Exclusion
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Previous treatment with any anti-CD27 antibody.
- Inadequate washout period from prior therapy as defined in the Protocol.
- Patients who have received more than 0 or 1 prior PD-1/PD-L1 inhibitor depending on their tumor type
- Major surgery within 4 weeks prior to study treatment.
- Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment.
- 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.
- Thrombotic events within the last 6 months prior to study treatment
- Active, untreated central nervous system metastases.
- Active autoimmune disease or documented history of autoimmune disease.
- History of (non-infectious) pneumonitis or has current pneumonitis.
- Active diverticulitis
- 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.
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04440943
Start Date
August 4 2020
End Date
April 6 2023
Last Update
June 18 2023
Active Locations (5)
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1
Northside Hospital
Atlanta, Georgia, United States, 30342
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
4
Duke Cancer Center
Durham, North Carolina, United States, 27710