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

Status
Active
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
NCT 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.

Eligibility

  1. 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.
  2. 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.
  3. 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
  4. Willingness to undergo a pre-treatment and on-treatment biopsy, if required. Additional Inclusion Criteria for Part 1:
  5. Advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, or indolent B-cell lymphoma are also eligible.
  6. Lymphoma patients must have received = 1 prior systemic therapy Additional Inclusion Criteria for Part 3:
  7. Patients must have documented progression while receiving anti-PD-1 or anti-PD-L1 based regimens for FDA approved indications
  8. Patients cannot have received more than one anti-PD-1 or anti-PD-L1 based regimen Additional Inclusion Criteria for Part 4:
  9. Patients must have metastatic pancreatic adenocarcinoma, and have not received previous treatment in a metastatic setting

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.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.