Study Details

Open

Study of RP1 in Organ and Cell Transplant Patients With Skin Cancer

This study is being done to look at the effects of an investigational drug, RP1, in patients with organ and hematopoietic cell transplant with advanced skin cancer (cutaneous squamous cell carcinoma).

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will meet with the study team to see if you are eligible for the study. You will have some tests done such as physical exam, heart and potentially lung tests, labs, and imaging. If you have visible tumors on your skin, the team will take photographs to determine if the size of your tumor changes with the investigational drug. If you are eligible, you will receive the investigational drug, RP1, by injection directly into the tumor. Imaging might be used to help the doctor inject deeper tumors. The drug dose may be given every 2 weeks for about 1 year. You might receive additional doses if you did not receive all doses and you have new lesions. You will come back to clinic for follow up visits to see how you are doing after the treatment. The visits will include exams, imaging, labs, and potentially photographs of your skin lesions. You may also be contacted by phone to complete study questionnaires.

In-person visits:
At least 16 clinic visits, possibly more if you continue taking the investigational drug

Total length of participation:
About 3 years

Looking for Specific Volunteers

Able to participate:

Solid organ or allogeneic hematopoietic cell transplant patients with confirmed recurrent, locally advanced or metastatic cutaneous squamous cell carcinoma
Must have progressed following local resection and/or prior radiation, and have received no more than 1 prior systemic therapy
If you received an organ transplant, documentation from transplant doctor that the organ transplant is stable
Adequate lab values per study protocol
Have archived tissue or will be willing to undergo biopsy at screening

Not eligible if:

Prior treatment with an oncolytic therapy
Active significant herpetic infections or prior complications of HSV-1 infection
Patients with a history of any positive test result for hepatitis B virus (HBV) or hepatitis C (HCV), or human immunodeficiency virus (HIV)
Radiation therapy within 14 days of first dose of RP1, or topical therapy within 30 days of RP1,
Has received a live vaccine within 30 days prior to the first dose of study drug.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Sid Sheth
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Other Cancers)

IRB Number

24-1990

ClinicalTrials.gov

NCT04349436