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A Phase 1, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of ARX517 in Subjects with Advanced Solid Tumors Resistant or Refractory to Standard Therapies

Clinical Trial Details

This clinical research study is investigating different doses of a study drug called ARX517, to see which dose is safe and has the fewest side effects, and whether or not it is effective in reducing tumor size in participants with prostate cancer or advanced solid tumor(s) with known prostate-specific membrane antigen (PSMA) expression who failed prior standard therapies.
   
The study drug, ARX517, is a type of manufactured antibody, known as an antibody-drug conjugate (ADC) that is attached to a toxin that may help to kill cancer cells. Antibodies are proteins naturally produced by your body to help fight infections. ADCs such as the study drug can also be produced in the laboratory as medications that help fight cancer.
   
The study drug is designed to stick to a protein on the cancer cell called PSMA. When the study drug sticks to PSMA, it is hoped that the cancer cells will die.
   
The study drug has not yet been approved in any country around the world, however, regulatory authorities such as the U.S. Food and Drug Administration (FDA) have approved testing this study drug in humans through clinical research studies such as this one.
   
Participation in this study includes ARX517 administration as an infusion through a vein in your arm, imaging scans (CT, MRI, PET, bone scan, brain scan), and tumor biopsy.

Key Eligibility: 
  1. Open to men and women above the age of 18 who have been diagnosed with advanced solid tumor malignancies 
  2. Received prior standard of care systematic treatment

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Angela Tan, RN
212-746-4154
ant4009@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2102023371

ClinicalTrials.gov:

NCT04662580

Sponsor:

ARX517-2011

Status

Open to Enrollment

Age Group

Adult

Sponsor