Breast Cancer Clinical Trial

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

Summary

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT04440943

Recruitment Status:

Active, not recruiting

Sponsor:

Celldex Therapeutics

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There are 5 Locations for this study

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Northside Hospital
Atlanta Georgia, 30342, United States
University of Chicago
Chicago Illinois, 60637, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
Duke Cancer Center
Durham North Carolina, 27710, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT04440943

Recruitment Status:

Active, not recruiting

Sponsor:


Celldex Therapeutics

How clear is this clinincal trial information?

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