A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies

Active:	No
Cancer Type:	Bile Duct Cancer Bladder Cancer Breast Cancer Colon/Rectal Cancer Esophogeal Cancer Gynecologic Cancers Head and Neck Cancer Hematopoietic Malignancies Liver Cancer / Hepatoblastoma Lung Cancer Melanoma Ovarian Cancer Primary Peritoneal Cancer Stomach/ Gastric Cancer	NCT ID:	NCT03329950
Trial Phases:	Phase I	Protocol IDs:	CDX1140-01 (primary) NCI-2018-00959
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Celldex Therapeutics Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT03329950

Summary

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40
antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or
chemotherapy and to further evaluate its tolerability and efficacy in expansion cohorts
once the MTD is determined.

Objectives

This study will determine the MTD of CDX-1140 while also evaluating the safety,
tolerability and efficacy of CDX-1140 alone (Part 1) or in combination with CDX-301 (Part
2), pembrolizumab (Part 3), or chemotherapy (Part 4) 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-1140. The dose-escalation part of the study
will test the safety profile of CDX-1140, alone or in combination with CDX-301,
pembrolizumab or chemotherapy and determine which dose(s) of CDX-1140 will be studied in
the expansion portions of the study.

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.

Treatment Sites in Georgia

Georgia Cancer Specialists - CenterPointe
1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD

Nishan H. Fernando MD

Pradeep C. Jolly MD

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Study Coordinator:

Anila Lokhandwala
404-256-4777 x9242

Doctors:

Rodolfo E. Bordoni MD

Nishan H. Fernando MD

Pradeep C. Jolly MD

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.