A Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03329950|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Non-small Cell Lung Cancer Breast Cancer Gastric Cancer Renal Cell Carcinoma Ovarian Cancer Cholangiocarcinoma Bladder Urothelial Carcinoma Pancreatic Adenocarcinoma Colorectal Cancer Esophageal Cancer Hepatic Cancer Head and Neck Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Other Solid Tumors Diffuse Large B-cell Lymphoma (DLBCL) Mantle Cell Lymphoma Indolent B-cell Lymphomas Non-Hodgkin Lymphoma||Drug: CDX-1140 Drug: CDX-301||Phase 1|
CDX-1140 is a fully human monoclonal antibody that binds to a cell receptor called CD40 expressed on certain cells and which activates the immune system, which then may promote anti-tumor effects in patients with cancer. CD40 is also expressed on some types of cancer cells and CDX-1140 may directly cause those cells to die.
CDX-301 is a growth factor for dendritic cells, a key cell type that regulates immune responses, including anti-tumor immune responses.
This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140 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, and determine which dose(s) of CDX-1140 will be studied in the expansion portions of the study.
Up to 140 patients will be enrolled for CDX-1140 monotherapy. Up to 40 patients will be enrolled for CDX-1140 in combination with CDX-301.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Part 1: Dose-escalation phase: Eligible patients will receive CDX-1140 treatments, based on cohort assigned, in 4 week cycles until progression or intolerance.
Expansion phase: To further study the safety, tolerability, and efficacy of CDX-1140. Patients enrolled in the expansion phase of the study will receive CDX-1140 at the dose level(s) chosen during the escalation phase.
CDX-1140 will be administered every 4 weeks.
Experimental: CDX-1140 and CDX-301
Part 2: Dose-escalation phase: Eligible patients will receive CDX-1140 treatments, based on cohort assigned, in 4 week cycles until progression or intolerance. A fixed dose of CDX-301 is injected once a day for five days before cycles 1 and 2 of CDX-1140.
Expansion Phase: To further study the safety, tolerability, and efficacy of CDX-1140 and CDX-301. Patients enrolled in the expansion phase of Part 2 will receive CDX-1140 at the dose level(s) chosen during the escalation phase and the fixed dose of CDX-301 from the Dose-escalation phase.
CDX-1140 will be administered every 4 weeks.
CDX-301 will be injected once a day for five days before Cycles 1 and 2.
- Safety and Tolerability of CDX-1140 as assessed by CTCAE v5.0 [ Time Frame: Within 35 days after first dose ]The rates of drug-related adverse events, serious drug-related adverse events, dose-limiting toxicities, laboratory test abnormalities, and maximum tolerated dose will be determined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329950
|Contact: Celldex Therapeuticsfirstname.lastname@example.org|
|United States, Arizona|
|HonorHealth Research Insititute||Recruiting|
|Scottsdale, Arizona, United States, 85258|
|Contact: Michael Gordon, MD 480-323-1350 Michael.Gordon@honorhealth.com|
|Contact: Melodi Priddy 480-323-1346 Melodi.email@example.com|
|Principal Investigator: Michael Gordon, MD|
|United States, Georgia|
|Northside Hospital, Inc.||Recruiting|
|Atlanta, Georgia, United States, 30342|
|Contact: Rodolfo Bordoni, MD 404-303-3355 firstname.lastname@example.org|
|Principal Investigator: Rodolfo Bordoni, MD|
|United States, Nebraska|
|Oncology Hematology West, PC dba Nebraska Cancer Specialists||Recruiting|
|Omaha, Nebraska, United States, 68130|
|Contact: Megan Meays 402-691-6971 email@example.com|
|Contact: Gladys Pierce 402-691-6972 firstname.lastname@example.org|
|Principal Investigator: Ralph Hauke, MD|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Tiara Hills 212-824-8449 email@example.com|
|Principal Investigator: Nina Bhardwaj, MD|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Danny Khalil, MD 646-888-4384 firstname.lastname@example.org|
|Principal Investigator: Danny Khalil, MD|
|United States, Ohio|
|Gabrail Cancer Center Research LLC||Recruiting|
|Canton, Ohio, United States, 44718|
|Contact: Carrie Smith 330-492-3345 ext 208 email@example.com|
|Contact: Brittany Dunn 330-492-3345 ext 213 firstname.lastname@example.org|
|Principal Investigator: Nashat Gabrail, MD|
|United States, Oregon|
|Providence Portland Medical Center||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Brenda Fisher, RN 503-215-2613 Brenda.Fisher@providence.org|
|Contact: Tara Foote, RN 503-215-7192 Tara.Foote@providence.org|
|Principal Investigator: Rachel Sanborn, MD|
|United States, Pennsylvania|
|Abramson Cancer Center at the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Sagan Loburak 215-614-7677 Sagan.Loburak@uphs.upenn.edu|
|Contact: Jennifer Louie 215-220-9668 Jennifer.Louie2@uphs.upenn.edu|
|Principal Investigator: Mark O'Hara, MD|