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Virus Therapy
Treatment for Squamous Cell Carcinoma
Phase 1 & 2
Recruiting
Research Sponsored by Sherrif Ibrahim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
"This trial is testing the effectiveness and safety of a treatment called RP1 for cutaneous Squamous Cell Carcinoma. Up to 12 patients will receive RP1 through injection directly into their skin tumors
Who is the study for?
This trial is for adults over 18 with resectable cutaneous Squamous Cell Carcinoma who haven't had treatment on the target lesion. They should be in good health, have a life expectancy over 2 years, and tumors between 1.0 and 3.0 cm in size that are visible and can be measured.Check my eligibility
What is being tested?
The study tests RP1, an investigational drug given by direct injection into the tumor of patients with Squamous Cell Carcinoma. It aims to evaluate its safety, tolerability, and effectiveness in up to 12 participants.See study design
What are the potential side effects?
While specific side effects for RP1 aren't listed here, similar treatments may cause reactions at the injection site, flu-like symptoms, fatigue, fever or chills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate degree of pathologic response at 16 weeks.
Secondary outcome measures
Evaluate presence of disease
Evaluate the duration of response
To estimate the complete response (CR) rate
+1 moreOther outcome measures
Survival rate evaluation
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Patients will receive RP1 via direct intratumoral (IT) injection into superficial cutaneous solid tumors to assess the safety and tolerability as well efficacy of RP1 treatment. The primary efficacy population is up to 12 evaluable patients with resectable CSCC.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Sherrif IbrahimLead Sponsor
Catherine VanHooft, HTStudy DirectorRochester Dermatologic Surgery
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals in total are enrolled in this research project?
"Indeed, the information on clinicaltrials.gov affirms that this investigation is actively seeking suitable participants. The trial was initially disclosed on June 16th, 2023 and saw its latest update on March 22nd, 2024. Enrollment aims to secure a total of 12 patients at one designated site."
Answered by AI
Who else is applying?
What site did they apply to?
Rochester Dermatologic Surgery
What portion of applicants met pre-screening criteria?
Met criteria
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