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Trial Title:
A Study of CDX-585 in Patients With Advanced Malignancies
NCT ID:
NCT05788484
Condition:
Non-small Cell Lung Cancer
Gastric Cancer
Head and Neck Cancer
Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Bladder Urothelial Carcinoma
Colorectal Cancer
Esophageal Cancer
Hepatic Cancer
Renal Cell Carcinoma
Cholangiocarcinoma
Pancreatic Cancer
Other Solid Tumors
Conditions: Official terms:
Carcinoma
Neoplasms
Cholangiocarcinoma
Fallopian Tube Neoplasms
Liver Neoplasms
Conditions: Keywords:
LILRB2
CD85d
ILT-4
PD1
Bi-Specific
Immunotherapy
Solid tumor Malignancies
Dose escalation
Immunological
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CDX-585
Description:
CDX-585 is administered by infusion every 2 weeks
Arm group label:
CDX-585
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 maximum tolerated dose of CDX-585 while also evaluating the
safety, tolerability, and efficacy of CDX-585 in patients with cancer.
Eligible patients that enroll to the dose-escalation portion of the study will be
assigned to one of several dose levels of CDX-585. The dose-escalation part of the study
will test the safety profile of CDX-585 and determine which dose of CDX-585 will be
studied in the expansion portions of the study.
Approximately 130 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.
The expansion portion of the study will further evaluate the safety of CDX-585 in
selected tumor types at the dose level chosen during the escalation part of the study.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Recurrent, locally advanced, or metastatic solid tumor cancer excluding primary
central nervous system tumors (e.g., glioblastoma).
2. Receipt of standard therapy for the tumor type in the recurrent, locally advanced,
or metastatic setting.
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-ILT4 antibody.
3. Patients who have received more than 1 anti-PD-1 or anti-PD-L1 targeted therapy,
including in the adjuvant setting.
4. Prior anti-PD-L1 based therapy within 12 weeks and prior anti-PD-1 based therapy
within four weeks to the planned start of study treatment.
5. 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 one year to be allowed to enroll.
6. Thrombotic events within the last six months prior to study treatment
7. Active, untreated central nervous system metastases.
8. Active autoimmune disease or documented history of autoimmune disease.
9. History of (non-infectious) pneumonitis or has current pneumonitis.
There are additional criteria your study doctor will review with you to confirm
eligibility.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
George Washington University Cancer Center
Address:
City:
Washington
Zip:
20037
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emilie Ginovker
Email:
emilie.ginovker@gwu.edu
Facility:
Name:
AdventHealth Celebration
Address:
City:
Celebration
Zip:
34747
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Whitaker
Email:
amy.whitaker@adventhealth.com
Facility:
Name:
Perlmutter Cancer Center at NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Phase 1 Clinical Research Team
Email:
PCC-Phase1@nyulangone.org
Facility:
Name:
Providence Cancer Institute
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tara Foote
Email:
canrsrchstudies@providence.org
Start date:
May 11, 2023
Completion date:
February 2026
Lead sponsor:
Agency:
Celldex Therapeutics
Agency class:
Industry
Source:
Celldex Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05788484
