A Phase I Study of 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-591) in Patients with Nonprostate Metastatic Solid Tumors: A Pilot Study

Study Status

Open to Enrollment

Study Description

The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.

We hope that 177Lu-J591 will seek out blood vessels that supply these tumors and deliver a dose of radiation (from the 177Lu molecule) to the areas of cancer, without affecting target blood vessel that are not associated with the cancer. 

177Lu-J591 is made up of two compounds called J591 and 177Lutetium (177Lu) that are joined together by a connecting molecule called "DOTA". J591 is a monoclonal antibody, or a type of protein. 177Lu is a radioactive molecule that is being tested for the possible treatment of cancer when joined to monoclonal antibodies. J591 attaches to a protein called prostate specific membrane antigen (PSMA) found in the body. PSMA is mostly found in normal and cancerous prostate cells. In addition, however, PSMA has also been found on the vasculature (blood vessels) that supply multiple types of cancer including colorectal, kidney, bladder, head and neck, breast, non-small cell lung, pancreas, ovary, esophagus and gliomas.

Disease Status and/or Stage

Metastatic Solid Tumor


Weill Cornell Medical College

Key Eligibility

  • Advanced stage, malignant adult solid tumors (except prostate cancer) that have not responded to standard therapy, or for which no curative standard therapy exists. This includes, but is not limited to, patients with cancers of the:
    • kidney
    • urothelium
    • head and neck
    • breast
    • non-small lung
    • colorectal
    • pancreas
    • ovary
    • esophagus
    • gliomas
  • Metastatic or recurrent solid tumor malignancy defined by abnormal CT, MRI, PET scan, chest x-ray and/or bone scan
  • Patients must have recovered from the acute toxicities of any prior therapy, and not have received chemotherapy, radiation therapy or other investigational anticancer therapeutic drug for at least 4 weeks prior to starting the study drug in this trial
  • Additional eligibility criteria discussed when you contact the study team

Principal Investigator

Scott Tagawa, MD


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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