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An Open-Label Study of Rovalpituzumab Tesirine in Subjects with Delta-Like Protein 3-Expressing Advanced Solid Tumors

Clinical Trial Details

This clinical trial is for men and women with advanced solid malignancies. 

The purpose of this study is to determine if rovalpituzumab tesirine can be administered safely and if rovalpituzumab tesirine is an effective treatment for different types of cancer that produce delta-like protein 3 (DLL3).  Your tumor will be tested for the DLL3 protein, but since testing for this protein is not a standard test, a positive result may not accurately predict whether or not the study drug will work in your case.

Rovalpituzumab tesirine (SC16LD6.5) is a type of study drug called an antibody-drug conjugate (ADC). Rovalpituzumab tesirine is made up of a monoclonal (from a single cell) antibody (substance that fights disease) that is linked to a very powerful form of chemotherapy.

Participants who are eligible and agree to go on the study will be given be given rovalpituzumab tesirine intravenously (IV, by vein) on the first day of each study treatment cycle. Each cycle is initially planned to be 6 weeks long.  On the first day of each cycle, participants will have a physical exam with vital signs, blood and urine tests, research blood tests, EKG, and echocardiogram.  Participants will also be asked to come in on other days during the cycle for

Participants will also have a CT or MRI scan every 8 weeks to assess the effect that the study treatment is having on their disease.  

Participants may remain on the study for as long as they are responding to therapy and not experiencing unacceptable side effects.  After participants complete study treatment, they will be contacted about every 12 weeks to check up on how they are doing.

Key Eligibility: 
  • Men age 18 and older.
  • Have one of the following kinds of  with tumors that express DLL3:
    • Malignant Melanoma
    • Medullary Thyroid Cancer
    • Glioblastoma
    • Large Cell Neuroendocrine Carcinoma
    • Neuroendocrine Prostate Cancer
    • High Grade Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NETs)
    • Other Neuroendocrine Carcinoma
    • Other Solid Tumors (not small cell lung cancer)
  • Have received prior treatment for advanced disease.
  • Detailed eligibility reviewed when you contact the study team.

Contact

Lauren Emmerich
lae9024@med.cornell.edu
(212) 746-1851

Primary Investigator

Himisha Beltran, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1604017191

Sponsor:

SCRX001-006

ClinicalTrials.gov:

NCT02709889

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Drug/Device

Drug

Study Type

Phase