A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
Bile Duct Cancer
Head and Neck Cancer
Liver Cancer / Hepatoblastoma
Primary Peritoneal Cancer
Stomach/ Gastric Cancer
18 Years and older, Male and Female
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
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.
- Recurrent, locally advanced or metastatic melanoma (including mucosal and/or ocular), bladder/urothelial, non-small cell lung cancer, pancreatic adenocarcinoma, breast, colorectal, gastric, esophageal, renal cell, hepatic, ovarian fallopian or primary peritoneal carcinoma, head and neck, and cholangiocarcinoma. Additional tumor types (except primary CNS tumors) may be enrolled after discussion with, and approval from, the medical monitor.
- Must have received all standard of care therapies (approved or unapproved) as deemed appropriate by the treating physician. Patients who refuse standard therapy are excluded from the study.
- 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. Additional Inclusion Criteria for Part 1:
- Advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, or indolent B-cell lymphoma are also eligible.
- Lymphoma patients must have received = 1 prior systemic therapy Additional Inclusion Criteria for Part 3:
- Patients must have documented progression while receiving anti-PD-1 or anti-PD-L1 based regimens for FDA approved indications
- Patients cannot have received more than one anti-PD-1 or anti-PD-L1 based regimen Additional Inclusion Criteria for Part 4:
- Patients must have metastatic pancreatic adenocarcinoma, and have not received previous treatment in a metastatic setting
Treatment Sites in Georgia
**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