DD03: RP1 in Organ Transplant Recipients with Advanced Cutaneous Squamous Cell Carcinoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the effects of an experimental drug called RP1 for kidney or liver transplant recipients with advanced Cutaneous Squamous Cell Carcinoma.

What is the Condition Being Studied?

Advanced Squamous Cell Carcinoma in organ transplant recipients

Who Can Participate in the Study?

Adults who:
- Are 18 years or older
- Have received a liver or kidney transplant
- Are diagnosed with advanced Cutaneous Squamous Cell Carcinoma (CSCC)
- Have not received systemic anti-cancer treatment for CSCC
- Have not received more than one previous local/topical therapy for CSCC

Age Group
Adults

What is Involved?

If you join this study, you will:
- Be treated with the study drug, RP1, 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

Study Details

Full Title
An Open-Label, Multicenter, Phase 1B Study of RP1 in Organ Transplant Recipients with Advanced Cutaneous Squamous Cell Carcinoma
Principal Investigator
Protocol Number
IRB: PRO00104981
NCT: NCT04349436
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698