An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies (ARTACUS)

Study Summary

The purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer. The skin cancer is either locally advanced (large tumors in the skin, muscles or nerves) or metastatic (spread to other parts of the body). This study will consist of a 28-day Screening Period, a Treatment Period, and a Follow-up Period. During the Treatment Period, patients will be dosed with RP1 every two weeks for up to 2 years (104 weeks). Tumor measurements will be done approximately every 8 weeks (and additionally if needed) until progressive disease, start of subsequent anticancer therapy, or completion/discontinuation of the study. During the Follow-up Period, patients will visit the clinic at 30, 60, and 100-150 days after their last dose of RP1 for safety and quality of life assessments. Patients will continue follow-up for up to 3 years from the day of the last patient's first dose.

Interventions

Study Locations

Facility	City	State	Country
Medical Dermatology Specialists	Phoenix	Arizona	United States
Mayo Clinic Arizona	Phoenix	Arizona	United States
University of California, San Diego	La Jolla	California	United States
University of California, Los Angeles	Los Angeles	California	United States
UCSF, Helen Diller Family Comprehensive Cancer Center	San Francisco	California	United States
University of Colorado Cancer Center School of Medicine	Aurora	Colorado	United States
Mayo Clinic Florida	Jacksonville	Florida	United States
University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida	United States
Moffitt Cancer Center	Tampa	Florida	United States
University of Chicago	Chicago	Illinois	United States
Dana Farber Cancer Institute	Boston	Massachusetts	United States
University of Michigan	Ann Arbor	Michigan	United States
Mayo Clinic Rochester	Rochester	Minnesota	United States
Washington University in St. Louis	St Louis	Missouri	United States
Columbia University Medical Center	New York	New York	United States
Rochester Dermatologic Surgery	New York	New York	United States
University of North Carolina Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	United States
Duke University	Durham	North Carolina	United States
University of Cincinnati	Cincinnati	Ohio	United States
The Cleveland Clinic Foundation	Cleveland	Ohio	United States
The Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States
Oregon Health and Science University	Portland	Oregon	United States
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States
University of Tennessee Medical Center at Knoxville	Knoxville	Tennessee	United States
University of Texas Southwestern	Dallas	Texas	United States
MD Anderson Cancer Center	Houston	Texas	United States
Inova Schar Cancer Institute	Fairfax	Virginia	United States
VCU Massey Cancer Center	Richmond	Virginia	United States

Official Trial Information

View on ClinicalTrials.gov