GA NCORP

NCORP Trials

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

Status
Closed
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
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03329950
Protocol IDs
CDX1140-01 (primary)
NCI-2018-00959
Study Sponsor
Celldex Therapeutics Inc

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


Georgia Cancer Specialists - CenterPointe
1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
Anila Lokhandwala
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
Northside Hospital Central Research Department
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