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
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 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0
Secondary Outcome
Objective Response Rate
Condition
Non-small Cell Lung Cancer
Intervention
CDX-527
Study Arms / Comparison Groups
CDX-527
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
27
Start Date
August 4, 2020
Completion Date
April 2023
Primary Completion Date
April 2023
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04440943
Organization ID
CDX527-01
Responsible Party
Sponsor
Study Sponsor
Celldex Therapeutics
Study Sponsor
, ,
Verification Date
March 2023