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ACTIVE NOT RECRUITING
NCT05858229
PHASE1/PHASE2

Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.

Sponsor: Sherrif Ibrahim

View on ClinicalTrials.gov

Summary

This is a Phase 1b, single-center, open-label study, evaluating efficacy and safety of RP1 for the treatment of resectable cutaneous Squamous Cell Carcinoma in up to 12 evaluable patients. In this study, 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. The enrollment of patients with CSCC will determine study duration.

Official title: A Phase 1B Study of Intralesional Injection of RP1 in Patients With Resectable Cutaneous SCC

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2023-06-16

Completion Date

2026-06

Last Updated

2025-12-31

Healthy Volunteers

Yes

Interventions

DRUG

RP1

Recombinant Herpes Simplex Virus Type 1 - hGM CSF/GALV-GP-R-

Locations (1)

Rochester Dermatologic Surgery

Victor, New York, United States