A Study Using the Research Drug Rovalpituzumab Tesirine (SC16LD6.5) to Treat Your Cancer (AbbVie Stemcentrx SCRX001-006)
Technical Title: An Open-Label Study of Rovalpituzumab Tesirine in Subjects with Delta-Like Protein 3-Expressing Advanced Solid Tumors
Disease Type: Cancers that produce a protein called Delta-Like Protein 3 (DLL3)
This is a research study of a drug called rovalpituzumab tesirine for the possible treatment of cancer. The purpose of this research study is to determine if rovalpituzumab tesirine can be administered safely and if it is an effective treatment for different types of cancer that produce a specific type of protein called Delta-Like Protein 3 (DLL3).
Rovalpituzumab tesirine is given intravenously (IV, by vein) in the clinic.
Research Procedures (not a complete list):
If you participate in this study, you will be given rovalpituzumab tesirine on the first day of each study treatment cycle, which is 6 weeks long. You will need to return to clinic for at least two cycles.
On the first day of treatment (Day 1), you will need to stay in clinic for at least 4 hours after you receive study drug for collection of research blood samples. A physical exam, safety blood and urine tests, cardiology tests (ECG and echocardiogram), will also be completed. You will also be asked to complete questionnaires about how you are feeling.
After Day 1, you will come to the clinic according to the following schedule:
During your first cycle, you will need to take another medication named dexamethasone to help prevent potential side effects of the study drug. You will need to take dexamethasone the day before your first dose of study drug, and for 2 days after.
You will continue to take the rovalpituzumab tesirine until your cancer no longer responds to treatment, or until you are no longer able to tolerate it.
Eligibility Criteria (not a complete list):
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