Purpose of this Study
We are doing this study to learn more about the effects of an experimental drug called RP1 (the study drug) for organ transplant recipients who have an advanced form of skin cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have received a liver, kidney, heart, lung, or other solid organ transplant
- Are diagnosed with an advanced form of skin cancer
- Have a tumor large enough to receive and injection
- Have stable transplant status
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you join this study, you will:
- Be treated with the study drug for 1 year (the study drug is given as injections directly into tumors)
- Return to the clinic for follow-up visits for 2 years after you finish taking the drug
- Have physical exams
- Answer questionnaires
- Have electrocardiograms (ECG) performed
- Have tumor biopsies done
- Give blood samples
- Have MRI and CT scans
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
An Open-Label, Multicenter, Phase 1B/2 study of RP1 in Solid Organ
Transplant Recipients with Advanced Cutaneous Malignancies
Transplant Recipients with Advanced Cutaneous Malignancies
Principal Investigator
Meenal
Kheterpal
Protocol Number
PRO00104981
NCT ID
NCT04349436
Phase
I/II
Enrollment Status
Open to Enrollment