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(DKN-0993) A Phase I, dose-escalation study investigating the safety and tolerability of intratumoral injection of an Fc-engineered anti-CD40 monoclonal antibody (2141-V11) in patients with cancer


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A Phase I, dose-escalation study investigating the safety and tolerability of intratumoral injection of an Fc-engineered anti-CD40 monoclonal antibody (2141-V11) in patients with cancer

Principal Investigator:
David Knorr MD, PhD

Investigators:

Contact Information:
Clinical Research Support Office
1230 York Avenue
New York, NY 10065
Telephone: 1.800.RUCARES
Email: RUCARES@Rockefeller.edu
Enrollment Status:
Open to Enrollment

Brief Summary of Protocol:
The purpose of this study is to test the safety and tolerability of a new drug called 2141-V11 in participants who have skin lesions associated with their cancer. It will also test how the body processes the drug and whether 2141-V11 has cancer fighting activity in humans.

The study drug is a modified antibody that has been designed to “wake up” a protein called CD40 which occurs naturally in the body and is used by the immune system to fight infections and cancer. Scientists at The Rockefeller University designed the modified antibody and it was manufactured at Massachusetts Biotechnology.




Detailed Description of Protocol:
The study drug will be injected into selected skin lesions of study participants once every 21 days and their responses to the drug will be monitored closely in follow-up visits. Many safety precautions will be taken throughout the study, including frequent monitoring visits and blood draws.

There are two parts to this study. Both Part I and Part II of the study will include adult participants with solid tumors and metastases to the skin that do not respond to standard treatment. The skin lesions must be identifiable to the investigator on exam by visual inspection or feeling the tumor under the skin. You will be enrolled in either Part I or Part II of the study.

This study involves multiple visits to The Rockefeller University Hospital. The administration of drug and follow-up visits will occur in cycles. A cycle is approximately 21 days. On Day 1 of each cycle, you will receive study drug injections(s) into your skin lesions. How many lesions will be injected at the visit will depend upon the number, size, and location of your lesions. You will have follow-up visits after every study drug injection to monitor for side effects from the drug, to determine how the drug is processed in your body, and to determine if the study drug is shrinking your lesion(s). The investigators will monitor the status of your cancer and your overall health. Each 21-day cycle will be repeated with drug injected on Day 1 of the following cycle unless your cancer progresses, you experience a serious side effect, or the study ends. The very first time you receive the study drug (Cycle 1, Day 1), you will need to stay in the hospital for at least 24 hours and up to 72 hours.




What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- At least 18 years of age
- Must have an identifiable lesion as a result of cancer spreading to skin
- Tumors must be accessible for biopsy


Gender:
Both

Age(s):
18-100

Children permitted to participate:
No

Potential Benefits.....
You may benefit from what we learn in this research study whether the study drug, 2141-V11, helps you or not. You may or may not have a reduction in the size of your skin lesions. Additionally, others may benefit in the future from what we learn from this study.



Compensation: